Method and apparatus for the treatment of tissue

ABSTRACT

This disclosure presents methods and devices for treating a defect in soft tissue of a patient. The methods and devices can employ fixation delivery apparatuses and fixation apparatuses positioned, at least in part, in or on the soft tissue to be repaired. In some aspects, these techniques include the use of this includes a fixation apparatus that includes at least one bone anchor connected to at least one tissue anchor by a shortenable elongate member.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.12/553,583, filed Sep. 3, 2009, now U.S. Pat. No. 8,163,022, which is acontinuation-in-part of U.S. application Ser. No. 12/251,295, filed Oct.14, 2008, now U.S. Pat. No. 8,128,698, which are herein incorporated byreference in their entirety.

TECHNICAL HELD

The invention generally relates to methods and devices for the closure,sealing, repair and/or reconstruction of an intervertebral disc annulus,and accompanying delivery devices and tools, and their methods of use.

BACKGROUND

The spinal column is formed from a number of bony vertebrae, which intheir normal state are separated from each other by intervertebraldiscs. These discs are comprised of the annulus fibrosus, and thenucleus pulposus, both of which are soft tissue. The intervertebral discacts in the spine as a crucial stabilizer, and as a mechanism for forcedistribution between adjacent vertebral bodies. Without a competentdisc, collapse of the intervertebral disc may occur, contributing toabnormal joint mechanics and premature development of degenerativeand/or arthritic changes.

The normal intervertebral disc has an outer ligamentous ring called theannulus surrounding the nucleus pulposus. The annulus binds the adjacentvertebrae together and is constituted of collagen fibers that areattached to the vertebrae and cross each other so that half of theindividual fibers will tighten as the vertebrae are rotated in eitherdirection, thus resisting twisting or torsional motion. The nucleuspulposus is constituted of soft tissue, having about 85% water content,which moves about during bending from front to back and from side toside.

The aging process contributes to gradual changes in the intervertebraldiscs. Fissures in the annulus fibrosus can occur due to various causes,including disease or other pathological conditions, or the natural agingprocess. Occasionally fissures may form rents through the annular wall.In these instances, the nucleus pulposus is urged outwardly from thesubannular space through a rent, often into the spinal column. Extrudednucleus pulposus can, and often does, mechanically press on the spinalcord or spinal nerve rootlet. This painful condition is clinicallyreferred to as a ruptured or herniated disc.

In the event of annulus rupture, the subannular nucleus pulposusmigrates along the path of least resistance forcing the fissure to openfurther, allowing migration of the nucleus pulposus through the wall ofthe disc, with resultant nerve compression and leakage of chemicals ofinflammation into the space around the adjacent nerve roots supplyingthe extremities, bladder, bowel and genitalia. The usual effect of nervecompression and inflammation is intolerable back or neck pain, radiatinginto the extremities, with accompanying numbness, weakness, and in latestages, paralysis and muscle atrophy, and/or bladder and bowelincontinence. Additionally, injury, disease or other degenerativedisorders may cause one or more of the intervertebral discs to shrink,collapse, deteriorate or become displaced, herniated, or otherwisedamaged and compromised.

The present inventors have found, advantageously and contrary toaccepted practice, that the annulus tissue may be repaired or otherwisetreated and that annular healing may be facilitated by reapproximation,reinforcement, and/or support of annular tissue. Methods and devices forcarrying out annular repair and/or reconstruction are a subject of thepresent invention.

SUMMARY

The present invention, in one embodiment, is a system for at leastpartially closing an aperture in an annulus fibrosus of anintervertebral disc adjacent to a vertebral body of a patient. Thesystem comprises a first fixation delivery apparatus, a first fixationapparatus, a second fixation delivery apparatus, and a second fixationapparatus. The first fixation delivery apparatus has a tubular shaft anda proximal handle. The first fixation apparatus is releasably coupled tothe first fixation delivery apparatus and includes a bone anchorconfigured to be deployed at least partially into and attached to avertebral body, and an adjustable flexible connecting element connectedto the bone anchor. At least a portion of the bone anchor and a portionof the adjustable connecting element are disposed within the tubularshaft of the first fixation delivery apparatus prior to deployment ofthe first fixation apparatus, and the flexible connecting element can bemanipulated by a user to adjust a length of thereof. The second fixationdelivery apparatus includes a tubular shaft having a sharpenedtissue-piercing distal tip, a proximal handle coupled to the tubularshaft, a releasable tab coupled to the handle, an ejection rod slidablydisposed within the tubular shaft, and an actuator slidably coupled tothe handle and operatively coupled to the ejection rod. The secondfixation apparatus is releasably coupled to the second fixation deliveryapparatus and includes a pair of tissue anchors and an adjustableflexible connecting element connecting the tissue anchors. The tissueanchors and a first portion of the flexible connecting element of thesecond fixation apparatus are disposed within the tubular shaft of thesecond fixation delivery apparatus, and a second portion of the flexibleconnecting element is coupled to the releasable tab of the secondfixation delivery apparatus prior to deployment. Additionally, the boneanchor is configured to be attached to the vertebral body, the tissueanchors are configured to be attached to the annulus fibrosus with theaperture located between the bone anchor and the tissue anchors, and theflexible connecting elements of the first fixation apparatus and thesecond fixation apparatus are configured to be interconnected and placedin tension to at least partially dose the aperture in the annulusfibrosus.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a primary closure of an opening in the disc annulus.

FIGS. 2A-2B show a primary closure with a stent.

FIG. 2C shows a method of affixing an annulus stent into the discannulus utilizing fixation points on vertebral bodies.

FIGS. 3A-3B show a still further illustrative embodiment of an annulusstent employing secondary barbed fixation devices.

FIG. 4A shows a herniated disc in perspective view, and

FIG. 4B shows the same disc after discectomy.

FIGS. 5A-5G show a still further illustrative embodiment of anintroduced and expanded annulus stent/patch being fixated and theaperture reapproximated.

FIG. 6 depicts an exemplary use of filler material within the apertureduring placement of a patch/stent tethered by a cinch line.

FIGS. 7A-7B depict a still further illustrative embodiment wherefixation means are placed into the vertebral body or the Sharpey fibers.

FIGS. 8A-8C show still further embodiments of the invention havingfixation anchors.

FIGS. 9A-9C show still further embodiments of the invention havingfixation anchors.

FIG. 10 shows a delivered configuration of fixation means that mayresult from the use of a single, or multiple, devices to delivermultiple barbs, anchor, or T-anchors sequentially or simultaneously.

FIGS. 11A-11B show an illustrative configuration of an anchor banddelivery device.

FIGS. 12A-12D show an anchor band delivery device comprising twodevices, each with at least one T-anchor and band with pre-tied knot andoptional knot pusher according to illustrative embodiments of theinvention.

FIG. 13 shows an anchor and band delivery device according to oneembodiment of the invention.

FIGS. 14A-14B show, respectively, a lateral view of a still furtherexemplary embodiment of the present invention having a braidedarrangement in a collapsed configuration and an axial view of theexemplary embodiment in an expanded configuration.

FIG. 15 shows a lateral view of the exemplary embodiment of FIG. 27A ina collapsed configuration mounted on an illustrative delivery device.

FIG. 16 shows a lateral cutaway view of the exemplary embodiment of FIG.27A in a collapsed configuration.

FIG. 17 shows a lateral cutaway view of the exemplary embodiment of FIG.27B in an expanded configuration.

FIG. 18 shows a lateral view of an illustrative delivery member as shownin the exemplary embodiment of FIGS. 16 and 17.

FIG. 19 shows a lateral view of an exemplary embodiment of the inventionin an expanded configuration subannularly.

FIG. 20 shows a transverse view of a treatment device mounted on adelivery tool in an unexpanded configuration in the subannular cavity.

FIG. 21 shows a transverse view of the treatment device being deployedinto an expanded configuration in the subannular cavity.

FIG. 22 shows a transverse view of the treatment device fully deployedand adjacent the annular wall.

FIG. 23 shows a transverse view of the placement of a fixation elementdelivery device into the deployed treatment device.

FIG. 24 shows a transverse view of the placement of a fixation elementthrough the treatment device and the annular wall.

FIG. 25 shows a transverse view after affixing a fixation elementdelivered in FIG. 24 and partial removal of the fixation elementdelivery device.

FIG. 26 shows a transverse view of the fixation element after removal ofthe fixation element delivery tool.

FIG. 27 shows a transverse view of an additional fixation element lockedin place on the opposite side of the treatment device.

FIG. 28 shows a transverse view of the removal of the treatment devicedelivery tool.

FIG. 29 shows an transverse view of an illustrative embodiment of atreatment device mounted on a delivery tool in an unexpandedconfiguration in the subannular cavity.

FIG. 30 shows a transverse view after affixing a fixation element to thetreatment device of FIG. 29.

FIG. 31 shows a transverse view of the placement of a fixation elementdelivery tool through the treatment device and the annular wall.

FIG. 32 shows a transverse view of the placement of an additionalfixation element through the treatment device and the annular wall.

FIG. 33 shows a transverse view after the removal of the fixationelement delivery tool.

FIG. 34 is a view of the anchor band delivery tool pre-deployment incross section.

FIG. 35 shows a detail of the distal end of the anchor band (fixationelement) delivery tool in cross section.

FIG. 36 shows a detail of the slide body and cannula anchor of anexemplary fixation element delivery tool in cross section.

FIG. 37 is a view of the anchor band delivery tool in cross sectionduring a deployment cycle.

FIG. 38 is a detail of the distal end of the anchor band delivery tooldepicted in FIG. 37.

FIG. 39 shows a detail of the slide body and cannula anchor of anexemplary fixation element delivery tool in cross section during adeployment cycle.

FIG. 40 shows a detail of the suture retention block and blade assemblyof the anchor band delivery tool.

FIG. 41 is a view of the anchor band delivery tool in cross sectionduring the cutting of the suture tether and release of the anchor band.

FIG. 42 shows a detail of the distal end of the anchor band deliverytool during release of the anchor band.

FIG. 43 shows a detail of the shows a detail of the suture retentionblock and blade assembly of the anchor band delivery tool during thecutting of the tether.

FIGS. 44A-44C illustratively show means that may be attached to theanchor band or anchor band delivery tool for providing perceptiblefeedback.

FIGS. 45A-45B depicts an anchor band assembly used to repair acircumferential tear in the annulus.

FIGS. 46A-463 show alternative illustrative mechanisms of drawingtogether locking elements/anchors.

FIGS. 47A-47B show alternative illustrative attachment mechanisms wherea pledget element that initially resides on outer annular surface.

FIGS. 48A-48E illustrate a fixation delivery apparatus and fixationapparatus in accordance with aspects of the present invention.

FIGS. 49-57B shows an exemplary treatment apparatus comprising anannulus fibrosus tissue anchor assembly coupled to a bone anchor via ashortenable elongate element, and the assembly and activation thereof.

FIGS. 58-64 show an alternative exemplary treatment apparatus comprisingan annulus fibrosus tissue anchor assembly connected to a bone anchorvia a shortenable elongate element, and the assembly and activationthereof.

FIG. 65 schematically illustrates a distal end of a hollow shaft on ananchor delivery tool, having three anchors disposed therein forsequential insertion.

FIG. 66 illustrates an alternative exemplary embodiment of a reparativeapparatus comprising at least one anchor assembly in a vertebra, atleast one anchor assembly in the annulus fibrosus, and at least onepatch member connected to both anchor assemblies with a shortenableelongate member also connecting the anchor assemblies.

FIGS. 67 and 68 illustrate alternative embodiments of anchor assembliesand associated shortenable elongate elements thereon.

FIG. 69 illustrates an exemplary anchor assembly having a plurality ofanchors connected by a shortenable coupling or connection therebetween.

FIGS. 70-71B illustrate an exemplary T-anchor type anchor constructcomprising a dual T-anchor implant, with two T-anchors shown ready forinsertion in series (FIG. 70) and those two anchors implanted andactivated in vivo (FIGS. 71A-71B).

FIGS. 72-73 show an alternative exemplary T-anchor type anchor constructcomprising a dual T-anchor implant, with two T-anchors shown ready forinsertion in series (FIG. 72) and those two anchors implanted andactivated in vivo (FIG. 73).

FIG. 74 illustrates a system for repairing an aperture or a defect in anintervertebral disc according to another embodiment of the presentinvention.

FIG. 75A is a partial cutaway illustration of a first fixation deliverytool and a first fixation device of the system of FIG. 73 according toone embodiment of the present invention.

FIG. 75B is a cross-sectional view of a portion of the delivery tool ofFIG. 75A taken along the line 75B-75B.

FIG. 76A is a partial cutaway illustration of a second fixation deliverytool and a second fixation device of the system of FIG. 73 according toone embodiment of the present invention.

FIG. 76B is a cross-sectional view of a portion of the delivery tool ofFIG. 76A taken along the line 76B-76B.

FIG. 77 is an elevation view of an alternative fixation delivery tooland fixation device coupled thereto according to another embodiment ofthe present invention.

FIG. 78 is a further illustration of the fixation device of FIG. 77.

FIG. 79A is a detailed view of a bone screw of the fixation device ofFIG. 77, and FIG. 79B is a cross-sectional view of the bone screw shownin FIG. 79A.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claim.

DETAILED DESCRIPTION

In the surgical repair of an aperture in the annulus, as shown in FIG. 1and as described in related commonly-assigned U.S. Pat. No. 6,592,625 toCauthen, a damaged annulus 42 is repaired by use of surgical sutures 40.One or more surgical sutures 40 are placed at about equal distancesalong the sides of a pathologic aperture 44 in the annulus 42.Reapproximation or closure of the aperture 44 is accomplished by tyingthe sutures 40 so that the sides of the aperture 44 are drawn together.The reapproximation or closure of the aperture 44 enhances the naturalhealing and subsequent reconstruction by the natural tissue (e.g.,fibroblasts) crossing the now surgically narrowed gap in the annulus 42.Preferably, the surgical sutures 40 are biodegradable, but permanentnon-biodegradable may be utilized. In all embodiments wherebiodegradable materials are indicated, suitable biodegradable materialsmay include, but are not limited to, biodegradable polyglycolic acid,swine submucosal intestine, collagen, or polylactic acid. Other suitablesuturing (and band) materials include, e.g., polymeric materials such aspolyethylene teraphthalate (PET), polyester (e.g., Dacron®),polypropylene, polyethylene, polycarbonate urethane or metallic materialinclude, e.g., titanium, nickel titanium alloy, stainless steel,surgical steels or any combinations thereof.

Additionally, to repair a weakened or thinned wall of a disc annulus 42,a surgical incision or dissection can be made along the weakened orthinned region of the annulus 42 and one or more surgical sutures 40 canbe placed at about equal distances laterally from the incision.Reapproximation or closure of the incision is accomplished by tying thesutures 40 so that the sides of the incision are drawn together. Thereapproximation or closure, of the incision/dissection enhances thenatural healing and subsequent reconstruction by the natural tissuecrossing the now surgically narrowed gap in the annulus 42. Preferably,the surgical sutures 40 are biodegradable, but permanentnon-biodegradable materials may be utilized.

Where necessary or desirable, the method can be augmented by placing apatch in and across the aperture 44. The patch acts as a bridge in andacross the aperture 44, providing a platform for traverse of fibroblastsor other normal cells of repair existing in and around the variouslayers of the disc annulus 42, prior to closure of the aperture 44.FIGS. 2A-B, for example, show a biocompatible device employed as anannulus stent 10, being placed in and across the aperture 44. Theannulus stent 10 acts as a bridge in and across the aperture 44,providing a platform for a traverse of fibroblasts or other normal cellsof repair existing in and around the various layers of the disc annulus42, prior to closure of the aperture 44. In some embodiments the device,stent or patch can act as a scaffold to assist in tissue growth thathealingly scars the annulus.

In an illustrative embodiment, the annulus stent 10 is a solid unit,formed from one or more of the flexible resilient biocompatible orbioresorbable materials well know in the art. The selection ofappropriate stent materials may be partially predicated on specificstent construction and the relative properties of the material suchthat, after fixed placement of the stent, the repair may act to enhancethe healing process at the aperture by relatively stabilizing the tissueand reducing movement of the tissue surrounding the aperture.

For example, the annulus stent 10 may be made from:

A porous matrix or mesh of biocompatible and bioresorbable fibers actingas a scaffold to regenerate disc tissue and replace annulus fibrosus asdisclosed in, for example, U.S. Pat. Nos. 5,108,438 (Stone) and5,258,043 (Stone), a strong network of inert fibers intermingled with abioresorbable (or bioabsorbable) material which attracts tissue ingrowthas disclosed in, for example, U.S. Pat. No. 4,904,260 (Ray et al.).

a biodegradable substrate as disclosed in, for example, U.S. Pat. No.5,964,807 (Gan at al); or

an expandable polytetrafluoroethylene (ePTFE), as used for conventionalvascular grafts, such as those sold by W.L. Gore and Associates, Inc.under the trademarks GORE-TEX and PRECLUDE, or by Impra, Inc. under thetrademark IMPRA.

Furthermore, the annulus, stent 10, may contain hygroscopic material fora controlled limited expansion of the annulus stent 10 to fill theevacuated disc space cavity.

Additionally, the annulus stent 10 may comprise materials to facilitateregeneration of disc tissue, such as bioactive silica-based materialsthat assist in regeneration of disc tissue as disclosed in U.S. Pat. No.5,849,331 (Ducheyne, et al.), or other tissue growth factors well knownin the art.

Many of the materials disclosed and described above representembodiments where the device actively promotes the healing process. Itis also possible that the selection of alternative materials ortreatments may modulate the role in the healing process, and thuspromote or prevent healing as may be required. It is also contemplatedthat these modulating factors could be applied to material substrates ofthe device as a coating, or similar covering, to evoke a differenttissue response than the substrate without the coating.

Materials of the patch could include a metallic material (e.g., NiTialloy, Stainless steel, Titanium), or a polymeric material (e.g.,polypropylene, polyethylene, polyurethane, polycarbonate urethane,polyetheretherketone (PEEK), polyester, PET, poly olefin copolymer,polypropylene, polyethylene), or a biodegradable or bioresorbablematerial (e.g., collagen, cellulose, polysaccharide, polyglycolic acid(PGA), a polylevolactic acid (PPLA), a polydioxanone (PDA) or forexample a racemic polylactic acid (PDLLA), or a combination of thesematerials.

In an alternative method of securing the annulus stent 10 in theaperture 44, as shown in FIG. 2C, a first surgical screw 50 and secondsurgical screw 52, with eyeholes 53 located at the top of the screws 50and 52, are inserted into the vertebral bodies, illustratively depictedas adjacent vertebrae 54 and 56. After insertion of the annulus stent 10into the aperture 44, an affixation element 40 is passed through thedisc annulus 42, adjacent to the aperture 44, through the eye hole 53 onthe first screw 50 then back up through the disc annulus 42 and throughthe orifice 18 on the annulus stent 10. This is repeated for the secondscrew 52, after which the affixation element 40 is secured. One or moreelements 40 are placed at about equal distances along the sides of theaperture 44 in the disc annulus 42. Reapproximation or closure of theaperture 44 is accomplished by tensioning elements 40 in such a fashionthat the sides of the aperture 44 are drawn, partially or wholly,together. The reapproximation or closure of the aperture 44 enhances thenatural healing and subsequent reconstruction by the natural tissuecrossing the now surgically narrowed gap in the annulus 42. Preferably,the elements 40, such as surgical sutures, are biodegradable butpermanent non-biodegradable forms may be utilized. This method shoulddecrease the strain on the disc annulus 42 adjacent to the aperture 44,precluding the tearing of the elements through the disc annulus 42.

FIG. 3A shows an alternative fixation strategy where a pair of barbs 134and 136 are plunged into the annulus fibrosus from the exterior of theannulus while the device 120 is retained in the sub-annular space bymeans of a tether 142. Although there are a wide variety of fixationdevices in this particular example, a tether 142 may be knotted 145 withthe band 144 holding the barbs 134 and 136 together to fix the device inthe sub-annular space. The knot is shown in an uncinched position toclarify the relationship between the tether 142 and the bands 144. Usingthis approach, the device can be maintained in a subannular position bythe barbed bands while the tether knot is cinched, advantageouslysimultaneously reapproximating the annulus to close the aperture whiledrawing the device into sealing, bridging engagement with the subannularwall of the annulus fibrosus.

FIG. 3B shows an alternative fixation strategy where the barbs 148 and150 are sufficiently long that they can pierce the body of the device120 and extend all the way through the annulus fibrosus into the device120. In this configuration, the band 144 connecting the barbs 148 and150 may be tightened to gently restrain and position the device 120 inthe sub-annular space, or tightened with greater force to reapproximatethe aperture or rent.

Another fixation means includes the passing of “anchoring bands” intothe wall of the annulus, vertebral bodies (superior, inferior, or both),of the Sharpey's Fibers (collagenous fibers between the junction of theannular fibers and vertebral bodies). In the following example ofanchors, the barbs or bands are affixed to the annulus/vertebralbodies/Sharpey's fibers. Another element, for example a suture, cinchline, or a staple is utilized to attach the anchor bands to the patch,and thus hold the patch in proximity to the inner wall of the annulus.In addition, these bands may re-approximate the tissues at the aperture.

Revisiting one example of using barbs to anchor the device is shown inFIG. 2C, described hereinabove. Barbs or bone anchor screws 50 and 52are passed into the superior and inferior vertebral bodies 54 and 56,respectively. Superiorly, affixation element 40 is passed through theouter wall of the annulus, to the sub-annular space. The element is thenpassed through the eyelet 53 of bone anchor 52 and then passed throughthe wall of the annulus from the sub-annular space to the outer wall ofthe annulus. The inferior end of the affixation element is similarlypassed through the annulus, eyelet of the bone anchor, and back throughthe wall of the annulus. Both ends of element 40 are tightened and tiedor otherwise secured. The advantage of this concept is that it allowsfor affixation of the stent device to a surface that is known to bepresent in all discectomy procedures—the vertebral bodies. Whereas, itis possible, depending on the location and size of a natural rent thatthere may not be sufficient annulus accessible to affix the patchdirectly to the annulus. In addition to providing a location foraffixing, anchoring into the vertebral bodies may provide a more stableanchor surface.

Patches can be folded and expanded in a single plane or in threedimensions. Collapsing the patch can be accomplished laterally, whetherthe device is a single material or composite. Others can collapse inthree dimensions, such as those shown in FIGS. 14, 17 and 21. Deviceswhich expand in three dimensions can optionally be packaged in arestraining sheath, jacket, gelatin shell or “gelcap”, or a mesh ofbiosorbable or dissolvable material, that would allow for facileplacement and subsequent expansion.

It is understood that there can be a variety of device designs ofpatches/stents/meshes/devices/treatment devices to accomplish theexpansion of a device from a first configuration, to a secondconfiguration to occupy at least a portion of the sub-annular space andreduce re-extrusion of the nucleus, or otherwise facilitate maintainingother intradiscal materials within the disc space. These devices can beconstructed of single components or multiple components, with a varietyof different materials, whether synthetic, naturally occurring,recombinated (genetically engineered) to achieve various objectives inthe delivery, deployment and fixation of a device to repair orreconstruct the annulus. The following device concepts are furtherdiscussed for additional embodiments of a device and/or system for therepair of an intervertebral disc annulus. The following descriptionswill illustratively depict and describe methods, devices, and tools todeliver a treatment to an intervertebral disc after a, lumbar discectomyprocedure; although, it is anticipated that these methods, devices, andtools may be similarly used in a variety of applications. As an example,the embodiments described herein may also advantageously maintainmaterials within the disc space other than natural disc tissue (nucleus,annulus, cartilage, etc.), such as implants and materials that may beused to replace and/or augment the nucleus pulposus or other parts ofdisc's tissues. These procedures may be performed to treat, for example,degenerative disc disease. Whether these materials are intended toreplace the natural functioning of the nucleus pulposus (i.e.,implantable prosthetics or injectable, in-situ curable polymer protein,or the like) or provide a fusion between vertebral bodies (i.e.,implantable bony or synthetic prosthetics with materials to facilitatefusion, such as growth factors like bone morphogenic proteins) oneskilled in the art would realize that variations to the embodimentsdescribed herein may be employed to better address characteristicdifferences in the various materials and/or implants that could beplaced within the subannular space, and that these variations would bewithin the scope of the invention.

Furthermore, it should be noted that surgeons differ in their techniquesand methods in performing an intervention on a spinal disc, and theinventive descriptions and depictions of methods, devices and deliverytools to repair annular tissue could be employed with a variety ofsurgical techniques; such as, but not limited to: open surgical,microsurgical discectomy (using a magnifying scope or loupes), minimallyinvasive surgical (through, for example, a METRx.® system available fromMedtronic, Inc.), and percutaneous access. Surgeons may also employ avariety of techniques for intra-operative assessment and/orvisualization of the procedure, which may include: intra-operativeprobing, radiography (e.g., C-arm, flat plate), and endoscopy. It iscontemplated that the inventive embodiments described are not limited bythe various techniques that may be employed by the surgeon.

In addition, the surgical approach to the intervertebral disc throughoutthe figures and descriptions depict a common approach, with relatedstructures, to a lumbar discectomy; although, it is possible thatsurgeons may prefer alternative approaches to the intervertebral discfor various applications (for example, different intervertebral disclevels such as the cervical or thoracic region, or for nucleusaugmentation), which may include, but is not limited to:posterior-lateral, anterior, anterior-lateral, transforaminal,extra-foraminal, extra-pedicular, axial (i.e., through the vertebralbodies), retroperitoneal, trans psoas (through the Psoas muscle),contralateral. The approach to the intervertebral disc space should notbe interpreted to limit the use of the invention for the repair orreconstruction of the an aperture, weakened or thin portion of theannulus, as described herein.

It is also important to note that the boundary in the intervertebraldisc space between the annulus fibrosus and the nucleus pulposus asdepicted herein may be demarked or otherwise highlighted; however, it isimportant to recognize that these tissues are not as precisely demarkedin human tissues, and may be even less so as the patient ages or evincesdegeneration of the intervertebral disc. This demarcation may beespecially difficult to discern during an operative procedure, using forexample; available surgical tools (i.e., probes), fluoroscopic guidance(x-ray), or visual (endoscope) guidance. However, in general, the layersof the annulus have more structural integrity (and strength) than thenucleus, and this integrity varies from the outer most layers of theannulus being of higher structural integrity than the inner most layersof the annulus.

Moreover, the drawings and descriptions herein are necessarilysimplified to depict the operation of the devices and illustrate varioussteps in the method. In use, the tissues may be manipulated by, and arefrequently in contact with, the various tools and devices; however, forclarity of construction and operation, the figures may not show intimatecontact between the tissues the tools and the devices.

As depicted in FIG. 4A, a herniated disc occurs when disc nucleusmaterial emerges from the subannular region and outside of the disc.Herniated disc nucleus material then impinges on nerve tissue, causingpain. A discectomy attempts to relieve pressure on the nerve tissuethrough surgical removal of disc material, the result usually being anaperture in the disc annulus wall, and usually a void in the subannularspace where disc nucleus was removed, as shown in FIG. 4B. FIG. 4Btypifies a disc after the discectomy procedure has been performed, as domost of the drawings and descriptions contained herein. However, itshould be understood that in order to perform a discectomy procedure,there are a variety of instruments and tools readily available to thesurgeon during spine surgery, or other surgical procedures, to obtainthe outcome as shown in FIG. 4, or other outcomes intended by thesurgeon and the surgical procedure. These tools and instruments may beused to: incise, resect, dissect, remove, manipulate, elevate, retract,probe, cut, curette, measure or otherwise effect a surgical outcome.Tools and instruments that may be used to perform these functions mayinclude: scalpels, Cobb elevators, Kerrison punch, various elevators(straight, angled, for example a Penfield), nerve probe hook, nerveretractor, curettes (angled, straight, ringed), rongeurs (straight orangulated, for example a Peapod), forceps, needle holders, nerve rootretractors, scissors. This list is illustrative, but is not intended tobe exhaustive or interpreted as limiting. It is anticipated that some ofthese tools and/or instruments could be used before, during, or afterthe use of the inventive methods, devices and tools described herein inorder to access, probe (e.g., Penfield elevator), prepare (e.g., angledor ringed curette, rongeur, forceps), and/or generally assess (e.g.,angled probe) treatment site or facilitate the manipulation (e.g.,forceps, needle holder), introduction (e.g., forceps, needle holder,angled probe), or deployment (e.g., forceps, needle holder, angledprobe) of the treatment device and/or it's components.

The are a variety of ways to affix a device to the sub-annular wall ofthe annulus. The following exemplary embodiments are introduced here toprovide inventive illustrations of the types of techniques that can beemployed to reduce the time and skill required to affix the patch to theannulus, versus suturing and tying a knot. Sutures, staples and otherfixation devices can be used to affix the patch to the annulus. In asimple example, a patch/stent could be compressed, passed through aguide tube and expanded within the sub-annular space.

Another fixation means includes the passing of “tissue anchoringelements” into the wall of the annulus, vertebral bodies (superior,inferior, or both), or the Sharpey's Fibers (collagenous fibers betweenthe junction of the annular fibers and vertebral bodies). In thefollowing example of anchoring elements, the barbs or bands may beaffixed to the annulus/vertebral bodies/Sharpey's fibers. Anotherelement, for example a suture, band, filament, cinch line, or a staplemay be utilized to attach the anchor elements to the patch, and thushold the patch in proximity to the inner wall of the annulus. Inaddition, these bands may also re-approximate the tissues of anaperture, weakened, delaminated, or thinned portion of the disc.

Another example of fixating the device to inner wall of the annulus isfurther illustrated by FIGS. 5A-5G. FIG. 5A shows a patch 702 that hasbeen folded and passed through a guide tube of a delivery too into thesub-annular space and then expanded. The patch is held by a deliverytool 704. Also shown is a anchor band or staple 709 and an anchor banddelivery device 708. Within the guide tube, or within the delivery tool,there is a suture line or cinch line 710 that is attached to the centerof the patch 702. In FIG. 5A, the guide tube has been removed. The guidetube is retracted after the patch 702 has been expanded and deployed.Next, as shown in FIG. 5B, an anchor band delivery tool 708 is used todeliver one or more “bands” 709 onto the outer surface of the annulus.These are intended to be anchored into the wall of the annulus with barbshapes that do not allow for the barbs to be pulled back through theannulus. The anchor bands resemble a construction of a “staple”. Thebands could actually be constructed by connecting two barbed elementswith, for example, a suture between the two barbed elements.

The barbs and the connection band between the barbs could be constructedof the same material or of different materials. For example, the barbedpart of the anchor band could be a biodegradable/bioabsorbable material(such as, for example, collagen, cellulose, polysaccharides,carbohydrates, polyglycolic acid, polylevolactic acid, polydioxanone,racemic polylactic acid) or could be constructed of a metallic orpolymeric biocompatible material (e.g., titanium, NiTi alloy, stainlesssteel, platinum, gold, polyurethane, polycarbonate urethane, polyimide,polyamide, polypropylene, polyethylene, polypropylene, polyester, PET,PEEK). The anchors could also be constructed of a combination of thesematerials. In addition, the band that connects these barbs can beconstructed of materials that are similar to the barbs, or differentmaterials. For example, the connection band could be abiodegradable/bioabsorbable suture, such as Vicryl, or a biocompatiblematerial such as polypropylene, polyethylene, silk, stainless steel,PET. In addition, it is possible that these elements are constructedfrom multiple materials to accomplish the objective of anchoring intothe annulus and providing for a fixation site to draw the tissuestogether.

FIGS. 5B and 5C show the placement of the anchor bands 709 into theannulus 712 with the anchor band delivery tool 708. FIG. 5D depicts arepresentative anchor band 709, having a pair of stainless steel barbs709″ connected by a suture 709. FIG. 5E shows the patch 702, anchorbands 709, and cinch line or suture 710 with the delivery tools removed,prior to drawing the patch and the tissues of the annulus together. Inthis embodiment there is a pre-fabricated slip knot 714 on the cinchline, although other locking elements or knots are possible. Sutureloops can connect to the barbs directly, as in FIG. 5, or loop tosurgical staples, or are placed directly into the annulus. The presenceof a pre-fabricated knot on the cinch line makes the process ofrepairing quicker since there is no need to tie a knot. It alsofacilitates drawing the tissues together. The use of the cinch line anda pre-fabricated knot can be placed by, for example, an external tubesuch as a knot pusher. FIG. 5E is similar to FIG. 3 describedhereinabove prior to “tying” the knot 714. FIG. 5F shows the drawing ofthe patch and the annular tissues together by puffing on the suture inthe direction “A” indicated by the arrow. In this case, the Knot Pusherhas been removed from the cinch line 710. The suture 710 is drawnproximally to draw the patch 702 into engagement with the inner wall ofthe annulus to seal the aperture from within, as well as draw the wallsof the annulus together to reapproximate the annular aperture. FIG. 5Gshows the cinch line suture 710 tied and drawing the annular tissuestogether, after the excess suture line has been cut. It is also apparentfrom this device, fixation and delivery system that the outer surfacesof the aperture may be drawn together for re-approximation.

The cinching of the anchor bands and the patch also allows for taking-upthe slack that allows for the accommodation of varying sizes. Forexample, the thickness of the annular wall surrounding the aperture canvary from 1 mm up to 10 mm. Therefore, if the anchor bands have a setlength, this design with a cinch line accommodates different dimensionsof the thickness of the wall of the annulus by drawing the “slack” ofthe bands together within the aperture.

Although it has been described here as patch placement that involves twolateral anchor bands or anchoring elements with a fixation element todraw the patch, bands and tissues together, one or two or more bandscould be used and two bands is only an example. Furthermore, the anchorbands were placed with the barbs in a superior-inferior fashion. Oneskilled in the art would recognize that these could be placed atdifferent locations surrounding the aperture. Moreover, although it wasdescribed that the anchoring elements are placed into the annulus, theseanchoring elements could also be placed in the vertebral bodies as shownin FIG. 7A generally at 800, or the Sharpey's Fibers 802, as shown inFIG. 7B generally at 804.

Although the patch depicted in the example above does not have barbsattached to the patch, it is also possible to provide barbs on orattached to the patch to further promote the fixation of the patch tothe inner wall of the annulus.

Finally, although the drawings depict an aperture that lends itself tore-approximating the tissues, it is conceivable that some apertures,whether natural or surgically made, may be relatively large andtherefore might require the placement of additional material within theaperture to act as a scaffold for tissue in growth, between the patch onthe inner wall of the annulus and the anchor bands located on the outerwall. An example of material to fill the aperture might includeautograft para-spinal fascial tissue, xenograft, allograft, or othernatural collagenous materials. The filler material could also be of abiocompatible material such as a Dacron (polyester, or PET),polypropylene, polyethylene material. FIG. 6 shows the illustrativefilling of an aperture with implant material 716 prior to cinching thesuture 710.

As an alternative embodiment of the present invention, the anchor bands709 as described previously (anchor bands into annulus) could besufficiently long enough to pass through the annulus and then throughthe patch. The barbs or anchoring elements in this embodiment have anengaging involvement with the patch. This concept was previouslydiscussed hereinabove in connection with FIG. 3. Passing the barbsthrough the patch, in this embodiment, provides additional security andsafety by reducing the possibility that the anchoring elements maymigrate after implantation. In this application of the invention, thesuture cinch line may or may not be used in addition to the anchor bandsto draw the tissues together and reduce tissue movement surrounding theaperture.

In addition, although the bands shown in FIG. 5 take the form of a“barb”, they could as easily take a form of a simple T-barb 720, or aC-type element wherein the object is to have irrevocable engagement withthe patch device 702 after the penetration through the patch. A T-typeattachment, when aligned longitudinally with the suture, passes throughthe patch. The T section then rotates to prevent the suture anchor frombeing pulled back through the patch. In another embodiment a “C”retainer made of a superelastic material may be attached to the end ofthe suture band. The C retainer is loaded into a needle wherein it isheld straight. The needle is used to pass the C retainer and suturethrough the patch and deploy the retainer hi a second configuration inthe shape of a “C”.

It is also foreseen within the scope of the invention that there may bepatch designs which will accommodate the placement and securement of theanchor to the fabric that covers the frame of the patch. For example, aframe for a patch that is made out of metal such as Nitinol can providefor “windows”. The device, covered with a mesh fabric, for examplesilicone or Dacron, would therefore allow the anchoring barbs to bepassed through the “windows” in the frame of the patch. In this case,the barb can be secured to the patch in the fabric covering the frame.

Alternatively, the patch can be secured by passing barbs that engage thelattice of the patch frame. These embodiments of the inventionillustrate designs in which the barbs engage with the vertical,horizontal or criss-crossed structures/members of the frame. In thiscase, the barbs would pass through the mesh or lattice of the frame andthey would be unable to pass back out of the structure.

Although this discussion refers to “anchor bands” that are shown to betwo anchors connected by a suture, it is also contemplated that singlebarbs with sutures could be placed and the sutures' ends, at the outersurface of the annulus, are tied after placement through the patch. Itis also possible that these “single anchors” could be retained by asuture “pledget” on the outer wall of the annulus to better hold theouter surface, or could include a suture (or band) locking device.

Alternatively, the locking mechanism can be as shown in FIG. 8, althoughin this case the engagement of the locking element 914 takes part on theanchor. Pulling the tether 910 in the direction of arrow B will tightenand lockingly hold in tension to aid in securement and tissueapproximation. The adjustable length band between the two anchors allowsslack to be taken up between the anchors 916. Two T-type anchors areillustratively shown in this example, but multiple anchors of differingconfigurations could be used. The locking features can be included onthe feature band, as depicted here, and allow for substantially one-waylocking engagement with the anchor members. This adjustabilityadvantageously promotes for the accommodation of varying thickness ofthe annulus from patient to patient. The suture/band slack in thisembodiment may be taken up to close the defect in the annulus and/or toshorten the band between anchors for a secondary cinching of multipletensioned suture bands as described herein.

FIG. 9 shows alternative embodiments for tightening “anchoring barbs”with different configurations of sutures and cinch lines. For example inFIG. 9B each independent barb has a looped suture attached to it.Through each of these loops is passed a cinch line, which contains aknot. After placement of the barbs within the annulus, and possiblythrough the patch, the cinch line draws the loops of the barbs together.The advantage of this embodiment is that it allows for the independentplacement of multiple barbs and the ability to draw all of themtogether.

Although cinch ones have been described as using a knot to “lock” thelength of the suture, other mechanisms could also lock the length, asshown in FIG. 8. The locking of the suture length is accomplishedthrough a mechanical element located on the barb which engages withthree dimensional elements attached to the suture line whichmechanically press fit through the engagement element on the barb, thuslocking the length of the suture line into place.

Although the embodiments of FIG. 8 and FIG. 9 depict the use of a singlelocking mechanism (e.g., knot on cinch line), it is conceivable thatvarious designs could use more than one locking element to achieve there-approximation and drawing together the tissue surrounding anaperture.

Similarly, an alternative embodiment to cause tension within the deviceand draw the tissues together after placement of the anchor bands mightinclude an elastic band or band with a spring with one end attached tothe anchor bands and the other end attached to the patch. Alternatively,the anchor bands, in and of themselves may be made of an elastic bandbetween the barbs, or may contain a spring element between the barbs.Such an embodiment can be made to resemble a so-called “Bobber Spring.”Again, it is contemplated that the elastic or resilient element could bemade from a wide variety of metals, polymeric, orbiodegradable/bioabsorbable material.

As previously mentioned, the present invention also encompasses deliverydevices or tools of the following description. The delivery devices ofthe present invention are configured to deliver at least one device, ora portion thereof, into (or through) the annulus or other surface ortissue, such as vertebral bodies 202, 204 or Sharpey's Fibers 802, asshown in FIG. 7. The delivery tools (or devices) will typically comprisedevices or shafts having proximal and distal ends. As referred toherein, the proximal portion of a device or tool or component willgenerally refer to the portion of the device/tool/component that islocated furthest away from the patient (and closest to the surgeon);whereas, the distal portion will generally refer to the portion that iswithin (in use) or closest to the patient (and therefore furthest awayfrom the surgeon). Although some of the device descriptions may refer tosome fixation element embodiments as being “fixation” or “anchor/anchorband/barb”, this is done for clarity reasons and should not bemisconstrued to suggest that the device is not capable of alsoperforming a treatment and/or a repair.

In addition, the following descriptions of delivery devices/tools aregenerally intended to be single-use and disposable; however, it is clearthat these tools could as easily be constructed to be partially, orwholly, re-usable and re-sterilizable.

An illustrative delivery device, as depicted in FIGS. 11-13, may beconfigured to accommodate and deploy at least one fixation device, suchas a barb or T-anchor with one or more associated bands. Advantageously,the distal end of the delivery device will comprise a hollow needle orcannula 711, having a circular, elliptical, triangular, hexagonal orother inner cross sectional area, suitable to accommodate thecross-sectional shape of the fixation device within. The distal point ofthe cannula 711 is advantageously sharpened, as a needle, to accommodateinsertion. The cannula 711 is advantageously cut obliquely as shown inFIG. 13 to form a sharp leading surface or point for ease of insertion.The cannula 711 may contain a cut or groove 718 along its side toaccommodate one or more anchors 709 as shown (or barbs, not shown),e.g., in FIG. 11B or 13. In one embodiment, the at least one fixationdevice (including band and barb or T-anchor), or portion thereof, isdisposed within the cannula 711 as shown in FIGS. 11A, 11B and/or 13.Alternatively, the T-anchor 709 (or barb, not shown), or other fixationdevice may be hollow and disposed in a manner surrounding a portion ofthe delivery device (not shown).

The delivery device 708 may also advantageously contain within it anejection rod 715. The proximal end of the ejection rod 715 may containan end portion 713 to function as a stopper, e.g., having a diameterlarger than the remaining portion of the rod, such as is shown in FIG.11A. The diameter of the remaining portion of the ejection rod 715 willbe small enough for insertion within the shaft of the device 708. Uponinsertion of the cannula 711 into the location of choice, the ejectionrod is pushed to deliver the fixation device. The delivery device isthen removed.

Advantageously, the ejection rod 715 and delivery device may beconfigured to deliver multiple fixation devices, sequentially orsimultaneously. Thus, if multiple fixation devices are contained withinthe device, the ejection rod 715 and delivery device may be configuredsuch that the rod 715 be pushed a first distance, sufficient to delivera first fixation device. The device is then removed from the firstinsertion point and inserted into a second insertion point, where theejection rod is then pushed a second distance for delivery of a secondfixation device, and so-on as desired. For simultaneous delivery ofmultiple fixation devices, multiple delivery devices may be arranged inparallel (or substantially parallel). The distance between (or among)the delivery devices may be fixed or adjustable, as desired.

The distance the ejection rod 715 is pushed to define a first, second,and subsequent distances may be regulated by feel. Alternatively, thedistance can be regulated by the architecture of the device. Forexample, the shaft and ejection rod may be fitted with anotch-and-groove configuration, respectively. In such configuration, thenotch in the outer surface of the ejection rod may be aligned with agroove in the inner surface of the device. The length of the groovedefines a first distance. The ejection rod 715 would be then turned orrotated within the device, aligning the notch within the device to asecond groove defining a second distance, and so-on. In an alternativeembodiment, the ejection rod and anchor portion of the fixation device(e.g., barb or T-anchor) may surround the shaft of the device, as asleeve surrounds an arm. In such a configuration, the delivery toolwould comprise a solid shaft and the ejection rod and fixation devicewould be at least partially hollow and disposed over the distal portionof the delivery device. Pushing the ejection rod in a proximal to distaldirection would deploy the anchor portion of the fixation device.

FIGS. 11A and 11B describe one embodiment of an anchor band deliverydevice 708 and fixation means. FIG. 11A shows a general drawing of adelivery device. FIG. 11B further depicts the distal end of the deliverydevice. Anchor band delivery device 708 contains two pointed needles orcannulas 711. Each cannula 711 contains an anchoring T-type anchor 709(or barb) positioned within the distal end of the cannula 711. A band709′ links the two anchors 709 (or barbs) together and a cinch knot 714secures the anchors (or barbs). Cinch line 710 is pulled to decrease thelength of the band 709′ that attaches the anchors 709.

Referring to FIG. 12A, anchor band delivery device 708 is inserted intothe annulus 712 sufficiently to engage the inner layers of the annulus712, and preferably located at the inner wall of the annulus 712. Theanchors 709 are ejected from the delivery device by pressing theejection rod 715 in a fashion to expel the T-anchors 709 (or barbs, notshown) from the device. For example, pressing on the proximal end ofejection rod 715 as shown in FIG. 11A drives the ejection rod 715 in adistal direction, thus expelling the anchor from the device. FIG. 12Bshows the anchors 709 (or barbs) after being ejected. FIG. 12C shows aknot pusher 716 attached to the delivery tool 708 that can be used totighten the knot 714 once the fixation device is secured into theannular tissue. FIG. 12C shows the placement of two pairs of anchors709, or fixation devices (anchors and bands), after they have beendelivered to the annulus and before the bands 709′ have been tightened.The knot pushers 716 of both devices are still in contact with the knotsand the delivery needles have been pulled back, away from the annulus.FIG. 12D shows the final placement of the two anchor bands after drawingtogether the tissues surrounding the aperture 717, the inner wall of theannulus 712, and/or the outer wall of the annulus; and, after tighteningand cutting the knot 714 located on each anchor band 709′. Although FIG.12 shows the passage of the bands superior and inferior to the aperture,these hands could also be placed in a multitude of locations to effectdesired or equivalent outcomes.

In addition, as previously described, one could use barbs having amultitude of configurations. One could also configure delivery devicesto deliver one (as in FIG. 13), two (as in FIG. 11A), or more barbssimultaneously, and according to predetermined or variable distances orpatterns. The delivery devices may also be configured to eject one, two,or more barbs sequentially. Further, the barbs could be delivered by adelivery device that does not require a cannula to cover the barb. Insuch a configuration, the barb may be disposed on the tip or outside ofthe delivery device's shaft, and removed therefrom upon injection intothe desired location of the annulus or other tissue. Bands and knots maybe pre-tied to accommodate each configuration, as previously discussed.

For example, although FIGS. 11 and 12A-B depict a device that places twoanchors 709 banded together with one device, one could accomplish anequivalent or other desired result with a single device that deliversmultiple barbs at the same time.

FIG. 13 shows an alternative delivery device that delivers two or moreanchors (or barbs) from a single cannula 711. In this embodiment, afirst single anchor 709 is ejected from the cannula 711 by pushing theejection rod 715 a first distance sufficient to eject the first anchor709, but insufficient to eject a second anchor 709″. Then the deliverydevice is removed from the first site and passed into another annularlocation. The second anchor 709″ (or barb) connected to the first anchor709 (or barb) by band 709′, is ejected out of the cannula 711 by pushingthe ejection rod 715 an additional distance sufficient to eject thesecond anchor 709 (or barb) into a second fixation point in the annulus.

Although much of this description has described placement of the anchorsinto the annulus (or soft tissue) of the disc, one could performanchoring into other tissues surrounding the aperture, including thebone or Sharpey fibers, it is also contemplated that, given the deliverydevice construction, a bone drill or similar device may facilitate theplacement of the delivery device through the bony or similar tissue.Alternatively, the device delivery tool and/or the anchoring element maybe of an architectural structure so as to enable the passage of theanchoring element into and/or through bony or similar tissue. Forexample, the device delivery tool may be of sufficient integrity so asto allow a physician to apply a force to the delivery tool with, orwithout, a mallet. Alternatively, the delivery tool distal end and/oranchoring elements may contain a serrated surface to facilitateplacement, as an example.

The band 709′ connecting the thus implanted anchors (or barbs)advantageously contains a moveable knot 714 between the anchors.Suitable knots include, but are not limited to, the Roeder knot and itsfunctional equivalents, and are advantageously, but not necessarily,pre-tied. After insertion of both anchors 709 (or barbs), the band 709′is advantageously tightened by hand or by pushing on the knot with aknot-pusher or similar device. Although not shown in FIG. 13, the knotpusher may be integral to the delivery device. After drawing togetherthe tissues surrounding the aperture, inner wall, and outer wall of theannulus, the excess suture line can be cut. It is also possible to use acutting device integral to the delivery device to cut the band aftercinching. Although the device shown in FIG. 13 depicts two anchors beingdelivered from a single device, multiple anchors or barbs could bedelivered from the same or a similar type of device. Additionally, adelivered configuration of fixation means may result from the use of asingle device to deliver multiple anchors sequentially.

The shaft of the device may be of any convenient length, typically from,e.g., 1 inch to 10 inches. Materials of which to make the deliverydevice include, but are not limited to: metals, such as stainless steel,nickel, titanium alloy, and titanium; plastics, such as PTFE,polypropylene, PEEK, polyethylene, and polyurethane, acrylic,polycarbonate, engineering plastics; and/or composites.

Advantageously, the shaft of the device will have a cross-sectionalshape suitable to accommodate an ejection rod and at least one fixationelement, or portion thereof. In one embodiment, at least a portion ofthe shaft of the device may be hollow, having a circular, elliptical,triangular, trapezoidal or other suitable cross-sectional areasufficient to accommodate an ejection rod.

The delivery device may also contain a handle or raised surfaceconfigured to accommodate the shape of surgeon's hands or fingers foreasier handling. Such raised or configured portion may be made of thesame or different material as the tube or shaft. Suitable materialsknown in the art include, among others, polymers, such as acrylicpolymers, polyurethane, polycarbonate, engineering plastics; and metals,such as stainless steel and titanium.

Much of the previous discussion relates to the use of a patch (or stent)for annular repair and/or reconstruction. In some clinical instances,the method of the invention may be accomplished without the use of apatch, however. For example, a patch may be unnecessary to repair smallapertures or apertures of certain shapes, or certain weakened or thinportion(s) of an annulus. The invention therefore also encompassesmethods for repairing or reconstructing annular tissue that do notnecessarily involve the use of a patch, and to fixation devices andtools useful in carrying out these methods, as exemplified in FIG. 12.Accordingly, an additional embodiment of the invention also providesfixation devices that may be used to reapproximate and hold annulartissue. Such fixation devices, as described herein, may contain ananchor portion and a band portion. The anchor portion serves to fix thefixation device relative to tissue. The band portion, attached to theanchor portion, serves to draw together annular tissue when tightenedand secured. At least one fixation device is placed into, or through,the wall of an annulus surrounding an aperture, weakened, or thinportion of the annulus. The device is then drawn in tension to pulltogether, wholly or partially, the surrounding annular tissue.

The band and the barbs may be separate elements or comprise onecontinuous element. Bands and barbs may be made of the same or differentmaterials.

The bands may be string-like, made from suture or similar material, orof any construction or dimension that is amenable to the delivery andengagement of the fixation device. For example, the band may have awidth greater than, in some embodiments far greater than, its thickness.The band material may in some embodiments have a width:height ratio of1.25:1. In some embodiments, bands may be constructed, wholly orpartially, of a mesh tube. Moreover, different segments along the lengthof the band may have different dimensions and constructions. Forexample, the band may be constructed of thin material, such as nickeltitanium ahoy or stainless steel wire, dose to the anchor barbs, whilethe middle portion that spans the aperture may comprise a much widerband made of optionally softer material.

FIGS. 8, 9 and 10 show additional examples of embodiments of theinvention for repair or reconstruction of the annulus that could beutilized without the additional use of a patch. For instance, in FIGS.8A-8C, in lieu of (or optionally in addition to) a patch, two anchorsare shown having passed through the annulus to the subannular space. Bydrawing on band 910, the inner and outer walls of the annulus may bedrawn together in tension, and may also reapproximate the tissuesurrounding the aperture. FIG. 8C shows a single anchor band beingplaced along an incision or tear in the annulus.

The fixation devices of the invention could be delivered as a pair ofbarbs attached by a single band, or each barb could be deliveredindividually Alternatively, multiple barbs (anchors) may be pre-attachedto a single or multiple bands for ease and speed of delivery. Forexample, FIG. 10 shows a fixation device that has multiple anchors 916(or barbs, not shown) connected together in a configuration similar toFIGS. 9B and 90, with each anchor 916 being delivered individually into,or through the nucleus or annulus. The anchors, if present, may be shownas in FIG. 10. By drawing on the cinch line, the tissues surrounding theaperture and/or the inner wall of the annulus and/or the outer wall ofthe annulus are drawn together. Although a knot 914 is shown to affixthe suture lines together, other means to lock, fasten clip, retain, orsecure the sutures together may also be used.

An additional exemplary depiction of fixation devices that may be usedto reapproximate and hold annular tissue as previously described inFIGS. 8-10 can be seen, for example, in FIG. 45. In FIG. 45, an anchorband assembly 308 and its complementary delivery tool 400, asexemplarily depicted in FIG. 25 and FIGS. 34-44 and FIG. 48, are used torepair a damaged, degenerated, weakened, or thin portion in anintervertebral disc annulus 232 having, for example, a circumferentialtear 247 compromising the integrity of the annulus. Anchor band assembly308 may draw in tension the annular tissue surrounding the tear 247 ordelamination of the annular laminae, helping to fortify, reconstruct,augment, repair, or otherwise reinforce the annular tissue.

A further exemplary embodiment of the invention in the form of a braidedpatch 1100 such as depicted in FIGS. 14-19, is a further illustrativeembodiment of the present invention that can be deployed into thesubannular space to act as a barrier to the extrusion of the nucleuspulposus, or other intradiscal material.

The “patch” 1100 is constructed from a braided tube of filaments 1102.The ends 1104 of the braided tube are heat-sealed to keep the braid fromunraveling and the seals also provide structural integrity to the patchwhen deployed. Although the devices described herein principally utilizeheat sealing for forming the ends of the device, there may be a varietyof ways to fixate, secure or otherwise form the ends of the devicethrough the addition of other materials to add structure to thefilaments, to include, but not limited to, the addition of collars orsleeves, dipping the ends in a material to fixate (i.e., heated polymer,adhesive). These added materials could be metallic or polymeric.

The braided patch 1100 is woven on a braiding machine with multiplefilaments 1102 to create the structure. For example, the patch can bewoven with 72 polyester filaments in order to create the construct thatreadily deploys into the annular defect, promotes tissue or matrixingrowth into the device, and retains an anchor after it has been placedthrough the wall of the annulus and through the patch. Changing thenumber of filaments 1102 in the patch, the material of the filaments,the dimension of the filaments (e.g., diameter), as well as theconfiguration of the filaments (e.g., cross-sectional area), or changingthe braid pattern, can create differences in the characteristics of thepatch. The braided patch can be made on a standard Steeger braider, orsimilar type braiding machine, that can handle braiding from anywherefrom 16 filaments at a time, to up to 196 filaments. Preferably thepatch is braided with between 32 to 144 filaments. In one exemplaryembodiment of the present invention, the device is braided with 72filaments of polyester filaments, with every other braid filament beingapproximately 0.012″ diameter, alternating with yarn (e.g.,approximately 64 microfilaments, each approximately 17 microns indiameter, bundled) or alternating with a polyester braid monofilamentapproximately 0.004° in diameter.

In addition, much of the description herein depicts devices thatgenerally have a tubular form, although it is also anticipated thatthese devices could be woven on the braider (i.e., by changing theconfiguration of the braiding mandrel), or re-formed in processing(i.e., heat forming) to obtain a patch construct that deviates from a“circular” cross section, in order to obtain different characteristicsof the patch pre, during or post deployment to accommodate anatomical,physical, and biological considerations of the patient or the deliveryof the implant. These device configurations may include square,rectangular, oblong, symmetrical, non-symmetrical, triangular, “cloverleaf”, or other cross-sectional constructions that may be partially(i.e., only in a portion of the device body, and/or only in a portion ofthe device ends), or completely present throughout the device.

The filaments 1102 of the patch can be made of different materials ordimensions, or all of the filaments in a patch can be of like materialand dimensions. The filaments can be biocompatible metallic material,such as a stainless steel, a nickel titanium alloy, or other metallicmaterials. The patch 1100 can also be made from biocompatible polymericmaterial such as polyethyleneteraphthalate (PET), polyester,polyethylene, polycarbonate urethane, polymethylmethacrylate, orpolypropylene, for example. It is also conceivable that the patch can bebraided from biodegradable materials, such as polyglycolic add (PGA),polylactic add (PLA), collagen (or its derivatives), fibrin (or itsderivatives), cellulose (or its derivatives), polysaccharides (or itsderivatives) or other biocompatible material that may degrade and/or bere-absorbed by the body over time.

It is also possible to braid the patch 1100 with multiple materialsand/or multiple dimensions of the filaments. For example, the patch canbe braided with 32 filaments of a polymeric PET material and 32filaments of polyester yarn material to create a patch that may beoptimal for sealing an annulus. The combination of different filamentmaterials, sizes, cross-sectional configuration, number of filaments,and braiding pattern can be used to construct a braided patch that canbe delivered into the sub-annular space, while acting as a scaffold toinduce healing of the aperture.

The braided patch has advantages in that it can be placed through anaperture in the wall of the annulus that is relatively small, but thenexpand to a dimension that is substantially greater than the aperture.For example, it is possible to construct the braided tube to be lessthan 5 mm in diameter, whereas in its fully deployed state it could begreater than, for example, 20 mm. This is exemplary and is not intendedto be construed as limiting in the actual dimensions of the device preand post deployment.

Referring to FIG. 15, the non-deployed braided patch 1100 is affixed onthe distal end of the patch delivery tool 1200. It is situated in afashion that is co-axial 1208 with the delivery tool's delivery members,which include inner delivery member 1202. A finger grip 1206 can beformed onto the proximal end of the delivery tool body to assist inmanipulation. Further detail of the deployment mechanism can be seen inFIG. 16. The braided patch 1100 is placed on the distal end of the innerdelivery member 1202. The heat-set distal cuff 1104 of the patch issituated within a depressed region on the distal region of the innerdelivery member 1216. The distal portion of the delivery member 1216 isslotted as shown in FIG. 18, and, in the non-deployed state, contains aco-axial retention member 1208 that acts to press the slotted potions ofthe inner delivery member apart, and thus securing the distal cuff ofthe patch 1104 on the distal region of the inner delivery member 1202.The proximal portion of the patch abuts and is in contact with an outerpusher member 1204. In the non-deployed state, the delivery device ispassed into the aperture of the annulus. Once inside the annularaperture, the outer pusher member 1204 of the delivery device 1200 ispushed toward the distal end of the device, while the inner deliverymember 1202 is pulled proximally. This action of moving these members insuch a fashion results in the braided patch expanding perpendicular totube's axis, as shown in FIGS. 14B and 17.

Once the patch 1100 has been expanded to its fully expanded state, acinch line 1212 that is connected to the distal and proximal ends of thepatch can be tightened and a knot, such as a Roeder knot, can be used tohold the braided patch in its expanded configuration. Although, thedevice is shown with a cinch knot 1214, it is possible that a lockingelement may not be needed, depending on the means used to fixate thepatch into the annulus. It is possible that no locking means isnecessary. It is also possible that alternative locking means can becontemplated to keep the braided patch in its expanded form. A knotpusher 1210 can also be employed to manipulate the knot locking device1214.

Once the device patch has been expanded into its final configuration inthe aperture and subannular space, the retention member 1208 can beremoved from the distal portion of the inner member by slidably pullingthe proximal end of the retention member in a proximal direction.Removing the retention member relieves the stress holding the distalcuff of the patch in place and allows the patch to be slidably removedfrom the distal end of the delivery device, and thus deployed into thesubannular space.

As depicted in FIG. 19, the patch 1100 can be affixed to the innersurface either before or after the deployment of the patch from thedelivery device. It is also contemplated that this patch can be affixedto the inner surface of the annulus by the various fixation meansdescribed in other parts of this application. For example, anchor bandsas shown in FIG. 19 could be used to penetrate the annulus 1306, shownbetween vertebrae 1302, and the patch to anchor the patch into thesub-annular space. It is also conceivable that single T-anchors 1310with a band 1314 (e.g., suture) could be delivered through the annulus1306 and patch 1100 with the portion of the suture on the outer surfaceof the annulus locked to the outer surface with a knot, pledget, orother locking device 1316. Path 1312 illustrates another possible suturepath through the bone of the vertebra to penetrate and hold a T-anchormember 1310 in the patch.

It is also conceivable that the patch could be affixed to the innersurface of the annulus through the use of adhesives, such ascyanoacrylate, fibrin glue, polymer protein, polyurethane, compoundsthat mimic mussel she adhesive proteins (manufactured by Nerites Corp.),adhesive materials that may be used as adhesives for dural or dermalwound repairs/sealing, or other material used to cure, or adhesivelyaffix the patch in the subannular space in situ. The delivery of theseadhesive fixation materials could be delivered through the patchdelivery tool, or through the anchor band delivery tool, or both. It isalso contemplated that if an adhesive were used to affix the patch tothe annulus that an additional membrane material may be added to thepatch device to further help restrict fluidic extravasation of thematerial out of the disc during adhesive delivery, if required.Conversely, the patch construction may be altered to reduce the patchporosity in order to accomplish a similar objective. Furthermore, it isanticipated that materials maybe added to, or changed, on portions thedelivery tools to reduce the possibility of the tools being adhesivelybonded to the instruments during delivery. For example, a cannula orother portions of a device used for adhesive delivery may be coatedwith, or be constructed of, PTFE, FEP, polypropylene, polyethylene orother lubriocious materials or coatings.

The advantages of the braided design, given the right selection offilament dimension, configuration, material, braid pattern, and numberof filaments is that it can be easily delivered to the annular repairsite, have the flexibility to take the shape of the annular defect whilemaintaining the mechanical integrity needed to remain within the discspace upon loading. Another advantage, again with the appropriateselection of material, filament configuration, braiding, dimensionalconsiderations, and multiple filament weaves, is that one can constructa patch that is conducive, in its deployed state, for incorporation offibrosis and the fibrotic healing of the annular defect. Finally, thepatch can be designed so that when it is in its delivered state, it caneasily receive one or more anchor bands through the braided filamentswhile retaining the T-anchor or other similar type fixation device,after passing the fixation device through the patch.

FIGS. 20-28 depict an illustrative method for the deployment of atreatment device into the intervertebral disc 200. As describedpreviously, there are a variety of applications, approaches, techniques,tools, and methods for accessing and performing spinal disc surgerywhich may be dependent on physician preferences and could be arbitrary.Therefore, the following description and depiction of the method shouldbe considered illustrative and not limiting. In the illustrativescenario which is used in the following descriptions, and with referenceto FIG. 20, the disc 200, which is comprised of the annulus fibrosus 232and the nucleus pulposus 234, is shown in a transverse cross section.The disc 200, as described above, is disposed anatomically betweencaudal and cephalad vertebral bodies, which a portion of a vertebralbody (spinous process 236) seen in FIG. 20. The disc 200 may be accessedfor treatment via a surgical incision 238 made in the paramedian regionlateral of the spinal canal 240. A microdiscectomy procedure may precedethe placement of a treatment device in order to remove disc fragmentsand to provide a subannular cavity 242. The subannular cavity 242,however, may be preexisting or may be created for the purpose ofperforming a nuclear augmentation An aperture 244 in the annulusprovides a path for the mesh or treatment device delivery tool 500 toplace treatment device 600. The treatment device 600 can take the formas described in the embodiments disclosed herein, or as additionallydescribed in commonly-assigned copending U.S. patent application Ser.No. 10/352,981, filed on Jan. 29, 2003 and incorporated herein byreference, or any other appropriate form. Likewise, the anchor banddelivery device 400 can take the form as described in the embodimentsdisclosed herein (e.g., with reference to FIGS. 34-44 and 48), asdescribed in commonly-assigned copending U.S. patent application Ser.No, 10/327,106, filed on Dec. 24, 2002 and incorporated herein byreference, or any other appropriate form.

As shown in FIG. 20, a delivery device 500 is introduced throughsurgical incision 238 to traverse aperture 244 and position treatmentdevice 600 in subannular cavity 242. As depicted, treatment device 600is in a first configuration sized to permit its passage to thesubannular cavity 242. FIG. 21 shows a detail, sagittal view of meshdevice 600 mounted on the distal portion 602 of delivery tool 500,introduced to the cavity. Also shown are sections of intervertebral disctissues. As illustrated, treatment device 600 may have element 608(FIGS. 29 and 30) to latch the mesh device once deployed into its finaldeployed configuration. If required, there may be a variety of ways tolatch, lock or otherwise secure the device in its final configuration.

As depicted in FIG. 21, the treatment device delivery tool 500 can bemanipulated by, for example, pulling a finger grip 502 in the directionof arrow 300 to deploy treatment device 600 in the subannular cavity242. As illustrated here, this deployment involves a longitudinalshortening of the treatment device, drawing end 606 toward end 604,resulting in a lateral expansion of the treatment device 600. Thepulling of the finger grip 502 may be preceded by the release of asafety lock 504 preventing deployment of the treatment device untilintended by the surgeon. As illustrated here, the lock is releasedthrough rotation of handle member 504 in the direction of arrow 302.Also shown is a marking 538 on the delivery tool 500 that may visuallyassist the surgeon in assessing the degree to which the device has beenplaced in subannular space.

FIG. 22 shows the finger grip 502 reaching its intended limit, and theconcomitant full intended deployment of treatment device 600, where end606 reaches its intended design position for the deployed configurationof the device 600. In this illustrative depiction, end 606 is pulledadjacent to end 604, and device 600 has reached its maximum intendedlateral expansion. As shown, the deployed device 600 may be pulled tointernally engage and at least partially conform to the cavity 242.Naturally, the full travel of the finger grip 502 can be determined bythe design of the delivery device, or informed by the judgment of thesurgeon through visualization, tactile realization, or the like. Oncethe intended limit has been achieved and the device fully deployed, thedelivery device 500 can lock finger pull 502 in place so as to maintainthe treatment device 600 in the deployed configuration. It may also beadvantageous for the delivery tool 500 to have a perceptible (i.e.,audible, tactile, visual) indication that the treatment device has beenfully deployed. The mesh/patch delivery tool 500 may be of the typedescribed hereinabove, or as additionally described in other sections ofthis disclosure.

FIG. 23 next depicts a fixation element or anchor band delivery device400 introduced through surgical incision 238, where the distal end 402is passed through the annulus fibrosus 232 adjacent to the aperture 244,and subsequently through treatment device 600, as illustrated by arrow190. Fixation element delivery tool 400 may have features to providetactile feedback once the delivery tool has been introduced into tissueto an acceptable extent, for example a feature like tissue-stop 432. Asillustrated, delivery device 400 is passed distally until stop 432 andpledget member 309 of the fixation device 308 come in contact with theouter surface of the annulus. Alternatively, and without tissue stop 432use, pledget member 309 could be of construction to similarly resist, orotherwise visually or tactilely indicate ceasing the passage of deliverydevice 400 through annular tissue. FIG. 31 shows a detail, sagittal viewof a distal end of a fixation element delivery tool 400 introduced intodisc tissue and through treatment patch 600. As shown in FIG. 31, onefixation element has been deployed and fixated. FIG. 31 also depicts anexemplary treatment device detection feature 442 on the outer surface ofneedle cannula 428, as more clearly illustrated in FIG. 35. The patchdetection feature 442 on the distal end of needle cannula 428 mayadvantageously provide perceptible feedback (tactile and/or audible) tothe surgeon that the anchor band delivery tool has accessed andpenetrated the patch and it is therefore acceptable to deliver the band.Feature 442 is discussed in more detail below. In operation asillustrated in FIG. 23 and in FIG. 24, the delivery device 400 can bemanipulated similarly to the treatment device delivery tool. Forexample, moving finger grip 404 in the direction of arrow 304 willwithdraw a portion (for example, the slotted needle cannula 428) ofdistal end 402 of the device 400 and deploy a fixation element 308 inthe subannular cavity 242 to secure the treatment device 600. Thepulling of the finger grip 404 may be preceded by the release of asafety lock 406 preventing deployment of the fixation element untilintended by the surgeon. As illustrated here, the safety 406 is releasedthrough rotation of safety 406 in the direction of arrow 306. Thefixation element delivery tool 400 may be of the type describedhereinabove, or as additionally described in, e.g., FIG. 34-44 or 48below, or in other areas of this disclosure.

FIG. 24 depicts the deployment of a fixation element, 308 into disctissue following the deployment of FIG. 23. The fixation device may beas described herein, for instance a T-anchor, suture, tether, knot,pledget or barb. As illustrated here, the fixation element 308 is aT-anchor with suture bodies, knot, and pledget as more fully describedherein. During the pulling of finger grip 404 and retraction of slottedneedle cannula 428, a knot pusher end 406 of inner cannula 426 is shownholding a proximal portion of the fixation device's 308 slip knot 440,while T-anchor 316 is drawn in tension proximally by tether or sutureline 310, to adjust the length of the fixation element 308 to providethe proper tension to securely hold the treatment device 600 in situ. Aproximal end of the fixation element, such as a pledget 309, is held orurged into engagement with a bearing surface on the exterior of theannulus. The proximal end of the fixation device can also include aT-anchor or knot or similar tissue locking element. FIG. 35 is a crosssectional view of the distal end of delivery tool 400 as it may beintroduced in disc tissue. FIG. 42 shows the distal end of the deliverytool 400 after retraction of the slotted needle cannula 428 andtensioning and drawing T-anchor 316 proximally to a potential finalstate. The proximal drawing of T-anchor 316 is also illustrated in adetail, sagittal view in FIG. 32, with arrows 324 illustrating motion ofthe T-anchor. The construction of the locking element 316 is exemplaryand is not intended to be limiting of alternative constructions of 316,such as one or more pledgets, knots, barbs or other forms to effect thesame function.

FIG. 25 shows the partial withdrawal of the fixation element deliverydevice once the fixation element has been deployed. In the illustrationsshown, the final step during the pulling of finger grip 404 proximallyresults in the release of the fixation element in situ. The release maybe accompanied by visual or tactile or auditory confirmation, such as aclick. Once released, the fixation element delivery tool can becompletely withdrawn as shown in FIG. 26, leaving the suture body 310 ofa fixation element extending through the surgical incision 238. Theproximal portion of suture body 310 may be cut to a suitable length withreadily available surgical tools such as a scalpel or surgical scissorsand removed from the surgical site. FIG. 30 shows a detail, sagittalview of a single deployed anchor band assembly 308 with T-anchor 316,pledget 309, slip knot 440 and associated tether components 318 and 310(after it has been cut in the epi-annular space). Also shown areportions or sections of intervertebral disc tissues. As shown, fixationelement 308 is fixedly engaged with the disc tissue and the patch 600.FIG. 27 depicts the treatment device 600 after placement of two fixationdevices 308, as does FIG. 33 shown in a detail, sagittal view. Ofcourse, any number of fixation devices appropriate to secure thetreatment device 600 can be used. It is also anticipated that device 600may be of a construction and design, as described herein, that does notnecessitate anchor bands to effect securement of device 600 within thedisc space and therefore, illustrations using fixation elements are tobe exemplary, and not limiting. Once secured, the treatment device 600is released from the delivery tool 500. As illustrated here, this isaccomplished in a two-step process. First the release mechanism isenabled by rotating knob 506 in the direction of arrows 312. Anindicator may then be activated as shown by arrow 320 of indicator 508in FIG. 28, such as spring-loaded release indicator 508 to notify thesurgeon that the treatment device has been released from the deliverytool 500. Accompanying the deployment of indicator 508 is the uncouplingof the treatment device 600 at the distal end 602. The delivery tool 500can then be withdrawn as depicted in the transverse view of FIG. 28,leaving treatment device 600 in situ.

FIGS. 34-44 depict illustrative embodiments of an fixation elementdelivery tool (or FEDT) as discussed herein, which may be referred toalternatively as an anchor band delivery tool (or ABDT). The fixationelement 308 is depicted as loaded in the distal end 402 of the ABDT,which will be discussed in greater detail with reference to FIG. 35. TheABDT 400 is comprised of a main body member 410 which may be fixedlyattached distally to outer cannula 422, and also to inner cannula 426 atinner cannula anchor 438. Distally, inner cannula 426, as betterillustrated in detail in FIG. 35, may comprise a knot pusher (or othermeans to effect securement of suture tethers 310 and 318 with lockingelement 440) and T-anchor stand-off 434. Proximally, main body 410 hasdisposed safety member 406 with an outside diameter telescopically androtatably received in the inner diameter of a knob 408. Knob 408 andmain body member 410 are rigidly attached to one another Slidablydisposed within the lumen of the main body member 410 is sutureretention block 414, depicted with suture body 310 threaded through itscenter hole. A spring 316 is also slidably disposed within the lumen ofthe main body member and can abut either suture retention block 414 orslider member 418. Slider member 418 can be integral with finger grip404 (not shown) as depicted in FIGS. 23-25. Attached to the proximal endof slider member 418 is a suture cutting blade assembly 420. The bladeassembly, as will be discussed in greater detail below, serves to severthe suture body after deployment of the fixation elements as describedherein. A slot in the slider member 418 allows the slider member 418 toslide past the outer cannula anchor 426 and, as described previously,426 may be stationary with respect to main body 410. A slotted needlecannula 428, slidably disposed in the lumen of the outer cannula 422, issecured the distal end of slider member 418 by needle cannula anchor430, such that the translation of the slider member 418 within main bodymember 410 concomitantly translates the slotted hypotube 428 within theouter cannula 422.

FIG. 35 is a detailed view of the distal end 402 of the ABDT 400. Asdescribed above, the slotted hypotube 428 is slidably received in theouter cannula 422. A tether, consisting of a suture line 318 and apledget body 309 is located in proximity to an optional tissue stop 432on the outer cannula 422. It is also possible for pledget 309 to be heldby an optional outer cannula pledget holder 433 until release of theanchor band. The suture line 318 is slidably knotted to suture body 310.The distal end of suture body 310 is attached to T-anchor 316, which isheld by T-anchor stand-off 434. As described above. T-anchor stand-off434 and knot pusher 436 may be components of inner cannula 426. In theinitial configuration, needle hypotube 428 extends distally of outercannula 422 and allows the point of slotted hypotube 428 to extenddistally of the T-anchor holder 434.

FIGS. 34 and 35 depict the ABDT in its initial delivery configuration.The ABDT is locked in this configuration by the distal end of safety 406engaging the finger grip 404 (not shown) as depicted in FIGS. 23-25.Turning now to FIG. 23, the rotation of handle member 406 in thedirection of arrow 306 allows the finger grip 404 (not shown) to engagea slot on safety 406, and permits the surgeon to pull finger grip 404proximally toward the proximal knob 408. Doing so results in thetranslation of the slider member 418 proximally; and concomitantly, theproximal translation of the slotted needle cannula 426 (as a result ofslotted needle cannula anchor 430) in the direction of arrow 326(illustrated in FIG. 32). The result, as discussed above, is theunsheathing by the needle 428 of T-anchor 316 held by T-anchor holder434. The translation of the slide body 418 proximally also urges thespring 416 and suture retention block 414 proximally. The sutureretention block 414 is attached to suture body 310, and thereforetension is leveraged onto the suture body 310 to hold it taught and,when appropriate, draw T-anchor 316 from within the delivery tool to aposition proximally.

FIGS. 37 and 38 illustrate the partial deployment of anchor bandassembly from ABDT, wherein slotted needle cannula 428 has beenpartially retracted to expose T-anchor 316. FIG. 36 is a detail, crosssectional view of the distal end of the handle of ABDT 400,illustratively showing the inter-relationships of delivery, toolcomponents in the initial configuration and FIG. 39 is a similar detail,cross sectional view showing the inter-relationships after at least apartial deployment of device 400. FIG. 40 is a detail of the sutureretention body 414, suture body 310, spring 316 and cutting assemblyblade 420, during partial deployment of delivery tool 400, as discussedabove. As depicted in FIG. 41 and detail drawings of FIGS. 42 and 43, asslider body 418 continues to slide proximally, in addition to continuingto draw T-anchor as shown in FIG. 42 with arrows, the tether retentionblock 414 reaches the limit of it's proximal translation (discussedfurther below), and the slider member engages and compresses spring 316.As the spring is compressed, the blade assembly 420, which is alignedwith the hole of suture retention body 414 through which suture body 310passes, comes into engagement with the suture body 310. FIG. 43 is adetail view of the blade 420 severing the suture body 310. Up to thelimit of travel of the suture block 414 and the severing of tether 310,the suture body 310 continues to apply tension to the T-anchor, as shownin greater detail in FIG. 42. With knot pusher holding knot 440, pledget309, and suture 318 in apposition, and in distally exerted fashion, tothe tensioning of suture body 310, anchor band assembly 308 isadvantageously cinched into a fixing and/or compressive relationshipbetween ends 309 and 316, as well as any structures (e.g., nucleus,annulus, treatment device) between elements 309 and 316. After severingsuture body 310, suture body 310 is still attached, to the anchor band,but has at this point been severed proximally. The suture body 310 willtherefore be unthreaded from the interior of the ABDT as the ABDT iswithdrawn. As discussed above the suture line 310 may be further cut tolength with readily available surgical scissors. Alternatively, asevering mechanism similar to those described herein in the distalportion of tool 400 may be employed to avoid an additional step oftrimming the end of body 310.

FIG. 40 is a detail of the suture retention body 414, suture body 310,spring 316 and cutting assembly blade 420, during partial deployment ofdelivery tool 400, as discussed above.

Additionally inventive of the anchor band device (and its delivery anddeployment tools) is the unique inter-relationship of the slide body,spring, and the tension delivered to the T-anchor and tissue duringdeployment. For example, T-anchor assembly can be designed to passthrough softer, or otherwise more pliable tissues (e.g., nucleuspulposus, softer annular layers) while resisting, under the sametension, passage through tougher tissues and/or substrates (e.g., outerannular layers, treatment device construct). In further illustrativedescription, tension delivered to the suture line 310 can be limited bythe interface between the slide body member 318 and the suture retentionblock 414, through spring 316 such that tension is exerted on T-anchorbody 316 which may sufficiently allow movement of T-anchor 316 throughsofter tissue, but alternatively requires a greater force to pullT-anchor body through other materials or substrates such as thetreatment device 600 or outer layers of the annulus 232. Spring 316 canbe designed to sufficiently draw tissues and/or the patch together,while not overloading suture line 310 when the fixation has beeneffected. Spring 318 may also be advantageously designed to allow bladeassembly 420, upon reaching an appropriate loading to effect thedelivery, to sever the suture line 310. As illustrative example, but notintended to be limiting, T-anchor body and suture line may beconstructed to require approximately 5 pounds of force to draw theT-anchor assembly through nuclear tissue, but substantially greater badto draw T-anchor through annular tissue and/or patch device. Spring maybe designed to exert approximately 5 pounds, sufficiently pulling anchorthrough nuclear tissue, and in proximity to treatment device, asintended. Once sufficient bad has been applied to move T-anchor toengage patch, the loading on the suture line is not allowed tosubstantially increase. Advantageously, additional loading would causethe final compression of spring between suture retention block and bladeassembly to sever suture line. Preferably, the severing and the designof the tether elements are such that the ultimate strength of the sutureline is greater than the bad required to draw T-anchor through softtissue, or the like, and less than the bad inflicted to cause thesevering by blade assembly. The description herein is intended to beillustrative and not limiting, in that other device and delivery toolscould be derived to employ the inventive embodiments.

With regards to introduction, delivery, deployment and/or fixation offixation element 308 as described previously and in particular, withregards to FIGS. 34-44, for example, anchor band assembly 308 and itsassociated delivery tool 400 may be described as effecting a fixation asshown in FIGS. 47A and 47B. FIG. 47A shows a pledget element 309 that,initially, may be placed on outer annular surface. As depicted, tether318 is attached to pledget 309, and pledget and tether are secured tosuture line 310 via a slip knot 440, for example. During deployment,T-anchor is drawn toward, and engaged with, treatment device 600 asillustrated in FIG. 47B. There may be alternative methods and mechanismsof drawing together locking elements/anchors 309 and 316, as exemplifiedin FIGS. 46A and 46B. FIGS. 46A and 46B illustrate a T-anchor member 316that may be positioned, initially, in proximity of patch 600. Asdepicted, tether 318 is attached to T-anchor, and T-anchor and tetherare secured to suture line 310 via a slip knot 440, for example. Duringdeployment, pledget 309 may be drawn to, and engage with, the surface ofouter annulus tissue, as illustrated in FIG. 46B. The description ofmethods of drawing members together and effecting a fixation of anfixation element with its fixation element delivery tools are intendedto be illustrative, and not limiting in the scope of the invention.

Since the surgeon's visualization of during discectomy procedures istypically limited to the epi-annular space and the aperture at theoutside surface of the annulus, any tactile, visual or audible signalsto assist, or otherwise enhance, the surgeon's ability to reliablydeliver and deploy treatment devices and/or anchor bands may beadvantageous. The anchor band delivery tool 400, may have a patchdetection feature 442 on the distal end of slotted needle cannula 428which may provide perceptible feedback (tactile and/or audible) to thesurgeon that the anchor band delivery tool has accessed and penetratedthe patch and it is therefore acceptable to deliver the band. As shown,detection feature 442 is composed of multiple bands or ribs although theouter surface of needle 428. The movement of the ribs of 442 against thepatch structure (e.g., the filaments of treatment device 600) mayproduce a clicking sound and feel, and the interface of the componentsof the devices and tools may be optimally designed to enhance suchfeedback features. One, or multiple, ribs or tabs may be utilized toachieve the perceptible features. The feed back may be perceived on orwith the patch and/or patch delivery tool or through the anchor bandand/or anchor band delivery tool, or both. FIGS. 44A-44C illustrativelyshows additional means that may be attached to the anchor band or anchorband delivery tool which might also provide perceptible feedback. Thesedepictions are meant to be illustrative and not limiting in scope of theinvention. FIG. 44A shows a tab 442 attached to needle cannula 428 whichmay be laser cut from the distal end of needle 428. Detection tab 442may be designed to readily pass through soft tissue and the patch 600without causing significant disruption, but may be capable due to itsdesign construction to produce tactile and/or audible sensation as itengages the patch lattice or structure. Lateral extent of tab 442 ofFIG. 44A may advantageously deflect, or otherwise deform or bend towardthe distal end of needle cannula upon removal of the delivery tool so asnot to be restricted by the lattice or structure of treatment device 600upon its removal. Alternatively, detection tab 442 of FIG. 44B isaffixed to, or integral with, T-anchor 316. Similarly, detection tab 442may be designed to readily pass through soft tissue and treatment device600 without causing significant disruption, but may be capable ofproducing tactile and/or audible sensation as it engages the patchlattice or structure. In this embodiment, tab 442 advantageously remainswith T-anchor 316 after removal of delivery tool 400. Moreover, it ispossible to have a detection feature 442 as depicted in FIG. 44C whereinthe feature is wholly, or partially, coaxial disposed on the deliverytool and feature 442 may be of a construction that does not readily passthrough patch 600, but it is capable of passing through soft tissue ofthe disc and produce a tactile and/or audible sensation as it engagesthe patch lattice or structure. Although some of the embodimentsillustrate a single tab or rib, it is possible to use more than a singleelement. Detection features described herein may be of a variety ofshapes and affixed to the devices or delivery tools (for example,welding ribs onto the surface of the delivery tool, affixing a flexiblefilament member to the T-anchor) or be incorporated as an integralcomponent thereof (for example, laser cutting or stamping tabs out of aportion of needle 428, injection molding tabs as part of t-anchor 316).Exemplary materials that could be used to construct the variousdetection features include, but are not limited to: biocompatiblepolymeric materials (polyester, polypropylene, polyethylene, polyimidesand derivatives thereof (e.g., polyetherimide), polyamide andderivatives thereof (e.g., polyphthalamide), polyketones and derivativesthereof (e.g., PEEK, PAEK, PEKK), PET, polycarbonate, acrylic,polyurethane, polycarbonate urethane, acetates and derivatives thereof(e.g., acetal copolymer), Polysulfones and derivatives thereof (e.g.,polyphenylsulfone), or biocompatible metallic materials (stainlesssteel, nickel titanium, titanium, cobalt chromium, platinum and itsalloys, gold and it alloys).

Although much of the description of the expandable braided treatmentdevice has illustrated the use of the braided construct as apatching-type element, the expandable braided element 1100, of forexample, FIGS. 14-18, could also be used to facilitate anchoring oftreatment devices depicted in, for example: FIG. 10 as anchor 916; FIG.1 as anchoring element 709; and/or AG, 19 as anchoring element 1310. Inthis use, the braided element may be delivered in an unexpanded state,and upon deployment and delivery obtain an expanded, anchored state. Twoor more of these braided anchor elements could be tethered to oneanother to effect the repair as previously described in, for example,FIGS. 10, 12 and 19. A braided expandable anchoring element could alsofacilitate anchoring into soft tissues of ligaments or annulus, or othertissues; such as, vertebral bodies 202, 204 or Sharpey's Fibers 802 ofFIG. 7.

As generally illustrated in FIGS. 48A to 48D, alternative embodiments ofpresent inventions include various additional fixation deliveryapparatus described previously as, for example, tool device or apparatus400. Fixation delivery apparatus in accordance with the presentinventions may permit the placement of a fixation apparatus describedpreviously as for example, 308 will now be further described by 450 inFIGS. 48A to 48D and within an intervertebral disc of a patient.Typically, the fixation delivery apparatus may be configured to deliverone or more anchors as described previously, and now will be furtherdescribed by anchor 451 in FIGS. 48A to 48D of a fixation apparatus 450into and/or through an intervertebral disc, which may include theannulus fibrosus, the nucleus pulposus, vertebral bodies and surroundingconnective tissues. The fixation delivery apparatus 450 may beconfigured to deliver multiple anchors 451, for example, a first anchor452 to a first location on an intervertebral disc and a second anchor453 to a second location on the intervertebral disc. The anchors 451 aretypically interconnected by one or more elongate members as describedpreviously and now will be further described by 454 in FIGS. 48A to 48D,such as bands, sutures, wires, and cables for example, which may becinched, tightened, reduced, or otherwise shortened so as to reduce thelength of the connection between at least a first anchor 452 and asecond anchor 453. Two or more elongate members 454 may includeretention devices and/or knots 455 as described previously tointerconnect the members and to permit the cinching of the elongatemembers 454. The cinching of the elongate members 454 may reconstruct,retain, stabilize, re-approximate and/or draw together tissuessurrounding a defect, tear, cut or delamination in the tissues of anintervertebral disc of a patient.

As generally illustrated throughout the FIGS. 48A to 48D, fixationdelivery apparatus 400 generally includes a delivery apparatus body 460,one or more shafts 461, actuators 462, and displacement rods 463. Thedelivery apparatus body 460 is typically secured to one or more shafts461 to allow a surgeon to position the distal end of the shaft 461within an intervertebral disc of a patient. Each shaft 461 may define alumen 464 and/or slot 465 which may removably receive at least a portionof at least one anchor 451 and or connecting band or loop 466. Adisplacement rod 463 may be positioned through at least a portion of thelumen 464 and/or slot 465. A displacement rod 463 may be axiallyslidable along at least a portion of the lumen 464 and/or slot 465 of ashaft 461. A displacement rod 463 may communicate with anchor 451 and/orfixation apparatus 450 to displace an anchor 451 from the lumen 464and/or slot 465 of a shaft 461. An actuator 462 may be movable by a userrelative to a delivery apparatus body 460. The actuator 462 may be incommunication with a displacement rod 463 to confer movement of thedisplacement rod 463 within the lumen 464 and/or slot 465 of a shaft 461such that at least one anchor 451 may be expelled from the lumen 464and/or slot 465 of the shaft 461 while the distal portion of the shaft461 is positioned proximate and/or within an intervertebral disc of apatient and the delivery apparatus body 460 and actuator 462 may bepositioned at least partially external to the patient to allow actuationby a surgeon.

In one aspect, a fixation delivery apparatus 400 may include a singleshaft 461. The shaft 461 may define a lumen 464 and/or slot 465 toserially receive two or more anchors 451. The tissue anchors 451 may besequentially dispensed from the distal end of the shaft 461 at one ormore locations within an intervertebral disc. In this embodiment, thedistally positioned anchor 451 may be particularly referred to as thefirst anchor 452 and the proximally positioned anchor 451 may beparticularly referred to as the second anchor 453. The anchors 451 aredisplaced from the lumen 464 and/or slot 465 of the shaft 461 by adisplacement rod 463. A displacement rod 463 may communicate with anactuator 462 so that a user may advance a displacement rod 463 withinthe lumen 464 and/or slot 465 to dispense anchors 451 from the lumen 464and/or slot 465 of the shaft 461. The first anchor 452 may be sized tobe frictionally held within the lumen 464 and/or slot 465, may beretained in the lumen 464 and/or slot 465 by one or more detents formedwithin the lumen 464 and/or slot 465, may be retained in the lumen 464and/or slot 465 by an elongated member 454 or other interconnectingmembers between anchors 451 and/or tethers 470, or may be otherwisetemporarily secured to the lumen 464 and/or slot 465 of shaft 461. Thesecond anchor 453 may be similarly secured to shaft 461 in a mannersimilar to a first anchor 452 or, alternatively, may be tethered by atether 475 to retain a second anchor 453 secured to lumen 464 and/orslot 465 during and/or after displacement of the first anchor 452 intothe intervertebral disc of a patient. In one aspect, the tether 475 maybe secured to the displacement rod 463 or the actuator 462. Before, orupon, or after placement of the second anchor 453, the tether 475 may besevered, broken, cut or otherwise released from an actuator 462,displacement rod 463, and/or the delivery apparatus body 460 or shaft461 to permit the release of the second anchor 453 from the structure towhich the tether 475 is secured. In this exemplary embodiment, the firstanchor 452 can be displaced from the shaft 461 by movement of thedisplacement rod 463 a first distance sufficient to displace the firstanchor 452. This first distance may be insufficient to displace thesecond anchor 453. Then, the shaft 461 of the fixation deliveryapparatus 400 may be moved from the first location where the firstanchor 452 was dispensed and repositioned at a second location on or inthe intervertebral disc to dispense the second anchor 453. The secondanchor 453 may be connected to the first anchor 452 by one or more bops466 and/or elongate members 454.

In another aspect, a fixation delivery apparatus 400 may include two ormore shafts 461. In an exemplary embodiment, wherein there are twoshafts, (similar to, for example, FIG. 11), one shaft may beparticularly referred to as the first shaft and the other shaft may beparticularly referred to as the second shaft. The first shaft and thesecond shaft may be adjacent one another and could be parallel to oneanother over at least a portion of their length (such as the cannulas711 illustrated in FIG. 11). Each shaft may define a lumen and/or slotto receive one or more anchors. In various configurations, the anchorsmay be simultaneously or sequentially dispensed at one or more locationswithin an intervertebral disc from the distal end of the respectiveshaft in which the anchors are positioned. In this embodiment, theanchor positioned in the first shaft may be particularly referred to asthe first anchor and the anchor positioned in the second shaft may beparticularly referred to as the second anchor. In this embodiment, afirst anchor can be displaced from the first shaft by movement of afirst displacement rod a distance sufficient to displace the firstanchor from the lumen and/or slot of the first shaft. A second anchormay be displaced from the second shaft by movement of a seconddisplacement rod a distance sufficient to displace the second anchorfrom the lumen and/or slot of the second shaft. The first displacementrod and second displacement rod may communicate with one or moreactuators to simultaneously or sequentially dispense the first anchorand the second anchor from the respective lumen and/or slot in whichthey are secured. The second anchor is typically connected to the firstanchor by one or more loops and/or elongate members. The first anchorand the second anchor may be sized to be frictionally held within therespective lumen and/or slot of first shaft and second shaft, may beretained in the respective lumen and/or slot by one or more detentswithin the lumen and/or slot or may be otherwise temporarily securedwithin the lumen and/or slot as described previously.

The delivery apparatus body 460 may be generally configured to provide auser with a structure to manipulate the distal portion of the shaft 461within a patient. The delivery apparatus body 460 may have an elongatedform and define a longitudinal aspect. In one aspect the proximalportion of the shaft 461 may be secured to a distal portion of thedelivery apparatus body 460. When the shaft 460 is secured to thedelivery apparatus body 460, the longitudinal axis of the shaft 460 maybe coaxial with the longitudinal axis of the delivery apparatus body460. In one aspect, the delivery apparatus body 460 may include a handle476 integral with the body, or secured to the delivery apparatus body460. When secured to the delivery apparatus body 460, the handle 476 maybe secured to the outer surface of the delivery apparatus body 460. Thehandle 460 is typically positioned to facilitate the manipulation of thefixation delivery apparatus 400 by a surgeon and may be particularlyconfigured to assist the surgeon in the positioning and/or dispensing ofa fixation apparatus 450 within a patient. In another aspect, thedelivery apparatus body 460 may include a raised textured surface forincreased friction between a user's hands and the fixation deliveryapparatus 400. The delivery apparatus body 460 may further cooperatewith the actuator 461 to control the movement of the displacement rod463 within a lumen 464 and/or slot 465 of shaft 461. In another aspect,the delivery apparatus body 460 may define a body cavity 477 to movablyreceive the actuator 462. The delivery apparatus body 460 may alsocomprise a tether access portal 478 (FIG. 48C) as a primary, orsecondary structure to access and/or sever the tether 475 to facilitatethe release of the fixation apparatus 450.

The delivery apparatus body 460 may be formed from a metal, polymericmaterial or other material that will be recognized by those skilled inthe art upon review of the present disclosure. Some exemplary suitablematerials recognized by those skilled in the art, include among others,polymers, such as acrylic polymers polyurethane, polycarbonate,engineered plastics; and metals, such as stainless steel and titanium.

The shaft 461 may be an elongate member that could be secured to anddistally extend from the delivery apparatus body 460. Although thevarious embodiments described and illustrated herein typically define adelivery device 400 configuration that extends along a longitudinalaxis, it is contemplated that the shaft and/or device components couldextend along different projections so as to provide better visualizationof the distal portions of the instruments within the surgical site. Forexample, it is possible that the handle and/or the proximal portion ofshaft 461 define a longitudinal axis that is at a different angle than,for example, the distal portion of shaft 461. With this configuration,the handle, in use, may extend from the surgical site at a lateralposition from the access incision and provide better visualization ofthe distal portion of shaft 461 within the surgical site. The shaft 461may define a lumen 464 and/or slot 465 in at least a distal portion ofthe shaft 461. The lumen 464 and/or slot 465 may be configured toreleasably secure one or more anchors 451, or portions thereof. Thelumen 464 and/or slot 465 may be particularly sized and shaped toreceive anchors 451 and the associated connecting loops 466 and/orelongate members 454, or portions thereof. The slots 465 may permitvarious components of the anchors 451 and/or elongate members 454(including components of anchors 451, bops 466 or elongated members 454such as retention devices and/or knots 455 or retention members, forexample) to extend from the shaft 461 at a distal portion of the shaft461. In one aspect, the lumen 464 and/or slot 465 may extend from theproximal end to the distal end of the shaft 461. In this configuration,the lumen 464 and/or slot 465 may communicate with the body cavity 477of the delivery apparatus body 460 at a proximal portion of the shaft461. In one aspect, the lumen 464 and/or slot 465 may be configured toslidably receive a filament 475. The lumen 464 and/or slot 465 mayextend distally to about the distal portion of shaft 461 and may extendto the distal tip of the shaft 461. The lumen 464 and/or slot 465 of theshaft 461 may have a circular, elliptical, hexagonal, pentagonal square,diamond, rectangular, triangular, or other cross sectional shape and maybe configured to releasably receive at least a portion of an anchor 451.In one aspect, the cross sectional shape of the lumen 464 and/or slot465 may correspond to the cross-sectional shape of the anchor 451. Inone aspect, the lumen 464 and/or slot 465 of shaft 461 may have across-sectional shape suitable to accommodate a displacement rod 463 andat least one anchor 451, or portion thereof. The lumen 464 and/or slot465 may have the same or a varying configuration along their length.

The distal tip of the shaft 461 may be generally configured to permitthe shaft 461 to penetrate the surface of an intervertebral disc orvertebral body using a force exerted by a surgeon on the deliveryapparatus. In one aspect, the distal tip of the shaft 461 may include asharpened tip. In another aspect, the distal tip of the shaft 461 may bechamfered to provide a point which may be sharpened to accommodateinsertion through at least a portion of the annulus fibrosus of anintervertebral disc. In one embodiment, the distal tip of the shaft 461may be cut obliquely to form a sharp leading surface or point for easeof insertion. In one embodiment, the device delivery tool and/or theanchoring element may be of an architectural structure so as to enablethe passage of the anchoring element into and/or through bony issue,such as the vertebral bodies. For example, the delivery apparatus may beof sufficient integrity so as to allow a physician to apply a force tothe apparatus (e.g., with, or without, a mallet). Alternatively, thedistal end of the apparatus and/or anchoring elements could contain aserrated surface.

A sheath 480 may be provided over at least a portion of the length ofthe shaft 461. The sheath 480 may function to reinforce the shaft 461.In alternative embodiments, the sheath 480 may provide a change indiameter longitudinally along the shaft 461 such that the penetration ofthe annulus fibrosus may be inhibited as the leading edge of the sheath480 contacts the annulus. In another aspect, the shaft 461 may include atissue stop 481 positioned relative to the distal end of the shaft 461to inhibit the penetration of the annulus fibrosus. Typically, thetissue stop 481 may inhibit the penetration of the annulus fibrosus byproviding a region of the shaft 461 with increased surface area. Thetissue stop 461 may be typically sized and shaped to efficiently inhibitthe penetration of the shaft 461 through the annulus fibrosus whilebeing relatively a traumatic to the tissues which it may contact.

The distal portion of the shaft 461 may include a tactile indicatorsimilar, as an example, to 442 of FIG. 35 to indicate that the distaltip of the shaft 461 has penetrated the intervertebral disc and/or apatch 600 in the case where a reparative fixation apparatus 450 is usedin conjunction with a reparative patch 600. The tactile indicator 442may be integrally formed from the material of the shaft 461 or may besecured to the shaft 461 to provide a tactile indication of properpenetration. Typically, the tactile indicator 442 is provided on anouter surface of the shaft 461, although it is possible for indicator tobe provided on other components of the delivery apparatus, such as thesheath 480 and/or the fixations apparatus, such as the anchors 451, aspreviously described in FIGS. 44A to 44C. The tactile indicator 442 maycomprise a series of ribs on the outer surface of the shaft 461 or maycomprise an external arm configured to “click” to an extended positionwhen the shaft 461 enters an area of increased diameter or a region ofsofter material within a patient.

The shaft 461 is typically from about 1 inch to 10 inches long. However,the length of the shaft 461 may vary considerably depending upon theconfiguration of the fixation apparatus 450 and the fixation deliveryapparatus 400, and may particularly depending upon the configuration ofthe delivery apparatus body 460 to which the shaft 461 may be secured,as well as the technique used to access the intervertebral disc space.The shaft 461 may be made from a wide range of materials having thedesired performance characteristics depending, at least in part, on theoverall configuration of the fixation delivery apparatus 400 and mayinclude: metals, such as stainless steel, nickel-titanium alloy, andtitanium; plastics, such as PTFE, polypropylene, PEEK, polyethylene, andpolyurethane, acrylic, polycarbonate, engineering plastics; and/orcomposites.

The displacement rod 463 may confer a motive force to anchors 451 todisplace one or more of the anchors 451 from the lumen 464 and/or slot465 of the shaft 461. In some embodiments, the displacement rod may alsofunction to withdraw one or more anchors 451 into the lumen 464 and/orslot 465. A portion of the displacement rod 463 may communicate withanchors 451 which may be least partially positioned within the lumen 464and/or slot 465 of shaft 461. In one aspect, the displacement rod 463extends through at least a portion of lumen 464 and/or slot 465. Thedisplacement rod 463 may be slidably received within the lumen 464and/or slot 465, in one aspect, the displacement rod 463 may be of asize and cross-sectional shape to correspond with the size and/orinternal shape of the lumen 464 and/or slot 465 in which at least aportion of the displacement rod 463 may be received. Although thecharacteristic of the displacement rod 463 may be typically of a unitarystructure, a displacement rod 463 in accordance with the presentinvention may include multiple components which act in conjunction withone another to displace the anchors 451 from the shaft 461.

In one embodiment, the displacement rod 463 may define a displacementrod lumen 482. In one aspect, the displacement rod lumen 482 may extendfrom a proximal portion to a distal portion of the displacement rod 463.The displacement rod lumen 482 may communicate with the body cavity 477of the delivery apparatus body 460 at a proximal portion of thedisplacement rod 463. In one aspect, the displacement rod lumen 482 maybe configured to receive a tether one, suture, wire, filament orotherwise elongate member. Tether 475 can be formed of multiplematerials and/or components to perform its function. In addition, atether passage 483 may be defined in the wall along the proximal portionof the displacement rod 463. The tether passage 483 may permit a portionof tether 475 to exit a displacement rod lumen 482 at a proximallocation or a location distal to the proximal end of the displacementrod lumen 482. The proximal portion of the displacement rod 463 maycommunicate with actuator 462 to actuate or regulate the movement of thedisplacement rod 463. In one embodiment, a proximal portion of thedisplacement rod 463 may be secured to actuator 462. The distal portionof the displacement rod 463 may typically communicate with at least oneanchor 451. In one aspect, the distal end of the displacement rod 463may communicate with the proximal end of anchor 451 to confer a motiveforce to the anchor 451.

In one exemplary embodiment, the displacement rod 463 can be advanceddistally a first distance, sufficient to dispense a first anchor 452.The shaft 461 of the fixation delivery apparatus 400 may be then removedfrom the first insertion point in the intervertebral disc and insertedinto the intervertebral disc at a second insertion point, where thedisplacement rod 463 may then be advanced distally a second distance todispense a second anchor 453, and so-on as may be desired for more thantwo anchors 451. Alternatively, for simultaneous delivery of multipleanchors 451, multiple shafts 461, each including a displacement rod 463,may be provided on the fixation delivery apparatus 400 and may bearranged adjacent to, parallel or substantially parallel along a portionof their lengths. In such configurations, the distance between theshafts 461 may be fixed or inter-operatively adjustable, as desired.When adjustable, the fixation delivery apparatus 400 may include amechanism, such as a ratchet or displacement mechanism (not shown), orotherwise, as will be recognized by those skilled in the art upon reviewof the present disclosure, to adjust the distances between the distalportions of the shafts 461. The multiple shaft embodiment may also beadditionally configured for sequential displacement of anchors 451.

An actuator 462 may communicate with one or more displacement rods 463or components thereof to assist a user in advancing the displacementrods 463 along the respective shafts 461. The actuator 462 may beconfigured as an enlarged body residing at the proximal portion ofdisplacement rod 463 which may be integral with, or secured to thedisplacement rod 463 to assist a user in advancing displacement rod 463.In this aspect, the distance the displacement rod 463 is pushed todefine a first, second, and subsequent distances may be regulated byfeel. Alternatively, the distance can be regulated by the architectureof the device. In this aspect, the actuator 462 may cooperate with thedelivery apparatus body 460 to control the advancing and/or retractingof the displacement rod 463 within shaft 461, for example as shown inFIG. 48.

Exemplary cooperation of actuator 462 and body 460 is shown in FIG. 48D,where the actuator 462 and delivery apparatus body 460 may cooperate byhaving a guide 484, such as a pin or projection for example, on onecomponent that is slidably received in a groove 485 or similar guidereceiving apparatus of the other component. In one such configuration,the guide 484 may be formed in, or positioned in, the body and/or thebody cavity 477 of the delivery apparatus and a groove 485 may bedefined by the outer surface of the actuator 462. The groove 485 mayextend longitudinally along and circumferentially (or laterallydepending upon the actuator's shape) around the actuator 462. Theactuator 462 may be slidably positioned in the body cavity 477 of thedelivery apparatus body 460 such that the guide 484 is received withinthe groove 485. The guide 484 extending from the body cavity 477 may bealigned within a groove 485 in the actuator 462 defined on the surfaceof actuator 462 such that the guide 484 is slidably received within thegroove 485 and tracks the groove 485 as the actuator 462 is moved withinthe body cavity 477. Thus, when the displacement rod 463 is mechanicallysecured to actuator 462, wherein the movement of the actuator 462corresponds one to one with the movement of the displacement rod 463,the movement of the displacement rod 463 will correspond to theconfiguration of the groove 485 on the actuator 462.

Fixation apparatus 450 as described herein may be various constructsutilized as primary reparative treatment of the soft tissues of thespine wherein re-approximation, reinforcement, stabilization, retention,reconstruction, and/or fixation as it would be otherwise achieve may benecessary for prophylactic or therapeutic repair of a defect, aperture,weakened, thinned or infirmed portion of the disc including the annulusfibrosus. In addition, fixation apparatus 450 described herein may beutilized in combination with other treatment constructs 600 such aspatches, membranes, scaffolds, barriers, stents (used interchangeably)wherein fixation devices may additionally enable a treatment device 600to be affixed to the soft tissue, including the annulus fibrosus, of thespine.

Fixation apparatus 450 may contain two or more anchors 451 and one ormore elongate members 454 or may contain one or more anchors 451, one ormore pledgets 309 and one or more elongate members 454. Furthermore, itis understood that multiple fixation apparatuses 450 may be usedtogether to perform a repair or other procedure. Anchors 451 maygenerally be configured to maintain a position within an intervertebraldisc as forces are applied to the elongate members 454. The one or moreelongate members 454 may typically be connected to a first anchor 452and a second anchor 453, or an anchor 451 and a pledget 309 and may beconfigured to apply a force between the first anchor 452 and the secondanchor 453 or the anchor 451 and the pledget 309, while allowing thecomponents to be drawn toward one another. One of the elongate members454 may be elongated and may function as a cinch line 470 that isaccessible to a surgeon after implantation of the anchors 451 of thefixation apparatus 450. In operation, the elongate members 454 securedbetween the anchors 451 may allow drawing together disc tissue, such asthe annulus, between the anchors 451 when tightened. Accordingly, thefixation apparatus 450 can be placed in tension applying a force to pulltogether, wholly or partially, the surrounding tissue of theintervertebral disc. The forces may be applied to reapproximate,reinforce, retain, reconstruct or otherwise fix a tear, defect,incision, rent and/or delamination in the intervertebral disc of apatient.

Anchors 451 are generally configured to substantially maintain a desiredposition within and/or on an intervertebral disc as tension is appliedto a band 454 or multiple elongate members 454 securing two or moreanchors 451 together. The anchors 451 are typically configured to permittheir positioning within and/or on an intervertebral disc using afixation delivery apparatus 400 and, once positioned and secured, toresist movement within the intervertebral disc. The anchors 451 may beconfigured as barbed anchors, T-anchors, coiled anchors, darts, conical,elliptical or other configurations as will be recognized by thoseskilled in the art upon review of the present disclosure. In anexemplary embodiment, a barbed anchor 451 may include an elongated bodyhaving at least one barb extending laterally from its longitudinal axis.One end of the elongated body may be particularly configured topenetrate the tissues of an intervertebral disc when the anchor 451 isdirected through tissue in a direction along its longitudinal axis. Inan exemplary embodiment, an anchor 451 may be connected to an elongatedbody, band 454, filament, filament loop or eyelet 466 secured at, nearor proximate its midpoint such that, after insertion in a longitudinalorientation, the anchor 451 tends to assume a position perpendicular toa line of force exerted by the loops 466 and/or band 454. Loops oreyelets 466 may be a rigid structure or may be a flexible structuredefining a loop through which a band 454 may be positioned. In oneaspect, the eyelets 466 are integral with or secured to the anchor 451and are a rigid structure, in another aspect, the eyelets 466 aresecured to the anchors 451 and are a flexible structure such as a wire,filament, line, tether or suture, for example, in an exemplaryembodiment of a coned anchor, a anchor 451 may include an elongated bodyin the form of a coil that is formed from flexible and resilientmaterial such that it may be insertable from a lumen 464 and/or slot 465in a shaft 461 in a substantially straightened or collapsed position andonce dispensed from the shaft may resume its original shape. In analternative exemplary embodiment of a coiled anchor, an anchor 451 mayinclude an open-wound, helically configured rigid element that may beattachably connected to the distal end of the shaft 461. Rotation of theshaft 461 or displacement rod 463 may, for example, advantageously“screw” the coned anchor into tissue of an intervertebral disc.

The anchors 451 may be elongated in shape. The anchors 451 may beintegral with or secured to elongate members 454. The elongate members454 can be secured to the anchors 451 through loops or eyelets 466 whichmay be integral with or attached to the anchors 451, can be secured tothe anchor 451 through one or more band passages extending into orthrough the anchors 451. In one aspect, a band passage may extendthrough the anchor 451 perpendicular to or substantially perpendicularto the longitudinal axis of the anchor 451. In other aspect, a bandpassage may extend through the anchor 451 at other angles relative tothe longitudinal axis of the anchor 451. Typically, the anchors 451 willbe configured to permit at least partial placement within a lumen 464and/or slot 465 of the shaft 461 of a fixation delivery apparatus 400.Alternatively, anchor 451 may have a defined cavity or passage to permitanchor 451 to be positioned at least partially over the distal tip ofshaft 461 of a fixation delivery apparatus 400. In this alternativeembodiment, anchor 451 may have a surface configured to pierce the softtissue of the intervertebral disc and allow delivery of the anchor 451,or may even have a surface configured to pierce or otherwise becomesecured to the bony tissue of a vertebral body.

The anchors 451 are typically formed from a substantially biocompatiblematerial of a metallic or polymeric biocompatible material such as, forexample, titanium, NiTi alloy, stainless steel, platinum, gold,polyurethane, polycarbonate urethane, polyimide, polyamide,polypropylene, polyethylene, polypropylene, polyester, PET, or PEEK, orcould be constructed from a biodegradable/bioabsorbable material suchas, for example, collagen, silk, cellulose, polysaccharides,carbohydrates, polyglycolic acid, polylevolactic acid, polydioxanone, orracemic polylactic acid. In addition, the anchors 451 can be constructedof a combination of these materials.

One or more elongate members 454 may interconnect anchors 451 and/orpledgets 309 of fixation apparatus 450. At a first end or region, theelongate members 454 may secured to one or more anchors 451. Theelongate members 454 may be tied to the anchors 451, may be mechanicallysecured to the anchors, may be integral with the anchors 451 or may beotherwise secured to the anchors as will be recognized by those skilledin the art upon review of the present disclosure. In one aspect, one ormore anchors 451 may be slidably secured to the elongate members 454 ormay be slidably received over the elongate members 454. Typically, oneor more elongate members 454 may be tied to one another with one or moreretention devices and/or knots 455 that may permit the cinching (orshortening) of the length of elongate members 454 separating two or moreof the anchors 451. The retention devices and/or knots 455 in the bandare typically movable along one of the elongate members 454 but may bemovable along two or more elongate members 454. The retention devicesand/or knots 455 are typically positioned between the anchors 451. Onesuitable family of retention devices and/or knots 455 include, but arenot limited to, the Roeder knot 455 and its functional equivalents.These knots may be pre-tied during the assembly of a fixation apparatus450. Alternatively, a mechanical element slidably received over a firstband 454 and secured to the end of another band 454 which is lockable ina desired position over the first band 454 may also be used. In anotheraspect, two or more anchors 451 may include loops or eyelets 466 whichmay be comprised of looped elongate members 454 through which a band 454in the form of a cinchable loop or “lasso” may be passed. The cinchingof the elongate members 454, or a bop in a band 454, allows fortaking-up slack and drawing towards one another intervertebral disctissues so as to reapproximate, retain, reinforce or otherwise repairtissues surrounding a disc tear, incision, defect, rent, infirmation ordelamination.

As noted previously, the elongate members 454 may be formed from avariety of materials. In one aspect, the elongate members 454 may beformed from sutures or suture materials commonly used by surgeons. Theelongate members 454 may be configured to have sufficient strength tore-approximate or draw together tissue surrounding tear, rent, incision,defect or delamination in the annulus fibrosus of a patient. In oneaspect, the elongate members 454 may be substantially inelastic to,among other things, permit a surgeon to sufficiently retain or draw thetissue of the intervertebral disc together by cinching the elongatemembers 454. In another aspect, the elongate members 454 may be formedfrom an elastic material and configured to be in a stretched positionupon implantation in a patient to apply a dosing force to a defect in anannulus fibrosus of a patient. The elasticity of the elongate members454 may also be selected to substantially correspond to that of theintervertebral disc of the patient. The elongate members 454 may bestring-like filaments having a construction and dimension, as disclosedherein and as will be understood by those skilled in the art upon reviewof the present disclosure, that are amenable to the delivery to andrepair of the intervertebral disc, as well as engagement with thefixation apparatus 450. For example, an elongate member 454 may have awidth greater than, in some embodiments far greater than, its thickness.When the elongate member 454 is formed from a suture or similarfilamentous material, the elongate member 454 may, in some embodiments,have a width:height ratio of 1.25:1. In some embodiments, elongatemembers 454 may be constructed, wholly or partially, of a mesh tube.Moreover, different segments along the length of the band may havedifferent dimensions and constructions. For example, the elongate member454 may be constructed of thin material, such as nickel titanium alloyor stainless steel wire, close to the anchor, while the middle portionthat may span the aperture may comprise a much wider band made ofoptionally softer material and/or a material that has a surface textureor porosity conducive to fibrotic ingrowth and repair or may beotherwise configured as disclosed elsewhere in the present disclosureand/or as will be understood by those skilled in the art upon review ofthe present disclosure.

In another embodiment, elongate members 454 and/or cinch line 470 mayincorporate a retaining element (not shown) so as to temporarily retainor otherwise constrain 454 and/or 470 along the delivery apparatus so asto facilitate the management of the members by the physician prior tothe physician's intent to delivery and/or deploy the treatment construct450. These retaining elements could act as collets in the proximalregion and/or the distal region of the delivery apparatus.

As noted herein, a patch-like device 600 in the form of a patch,membrane, scaffold, barrier, stent, sealing device, reinforcement, plug,occlusion device, or otherwise, may be provided for repair,reconstruction, reinforcement, re-approximation, or otherwise treatmentof apertures, weakened, thinned or otherwise infirmed tissue such astears, rents, defects, delaminations and/or incisions within anintervertebral disc. In one embodiment, an apparatus 600 may used incombination with other reparative apparatuses, such as fixationapparatus 450, for the re-approximating, reinforcing, or otherwiserepairing tissues. Particularly, it is conceivable that some natural andsurgically made defects may be relatively large and accordingly,reapproximation of tissues surrounding an aperture is not actually orpractically possible without the introduction of additional material, Adevice 600 in accordance with the present inventions may provide thematerial for positioning in and around a defect to bridge some; all or aportion of the defect to facilitate a medically appropriatestabilization of the tissues. The patch 600 may function to reinforcethe portion of an intervertebral disc through which a fixation apparatus450 is implanted. And, patch 600 may be used to bridge tissues of adefect and may also act as a scaffold for tissue ingrowth.

The patch 600 may be configured as a membrane, webbing, mesh,scaffolding, barrier or otherwise as will be recognized by those skilledin the art upon review of the present disclosure. The patch 600 may beof a rigid construction, may be flaccid, or may of an intermediaterigidity. The patch may also have configurations that include multiplerigidities associated with different portions of the patch as may benecessary to address alternative defect pathologies and/or delivery anddeployment considerations. The patch 600 may be of a solid material,webbing or otherwise, or may comprise one or more mounting cavitieswithin the patch. In one aspect, the mounting cavities or receptaclesmay cooperate with a patch insertion tool 500 to assist in the placementof the patch 600. In one aspect, the patch 600 defines a single patchmounting cavity extending along its length and, accordingly, may beconfigured as a sleeve or a sock. In alternative embodiments, the patch600 may define a plurality of mounting cavities which are configured toreceive one or more projections, brackets, arms or otherwise mounting orretaining elements 504 or 506 of the patch insertion tool 500.

Patches 600 can be formed from a variety of materials or combinations ofmaterials known to those skilled in the art. These materials aretypically biocompatible. The patch 600 may be configured from natural orsynthetic materials including, but not limited to, various polymers,metals and biological tissues, for example, in one aspect, the patch 600may be formed from autograft para-spinal fascial tissue, xenograft,allograft, or other natural or processed collagenous materials. Thematerial could also be polymeric such as a Dacron (polyester, or PET),polypropylene, polyethylene, polymethylmethacrylate, PTFE, CPTFE,Surlyn, or PEBAX material, for example. In some exemplary embodiments,the patch 600 could comprise biocompatible metal, such as NiTi alloy,chromium cobalt alloy, titanium, stainless steel or the like. Webbingmaterials could also be woven or non-woven, or braided. Patches may alsobe partially or wholly constructed from biodegradeable or bioabsorbablematerials, it is also possible for the patches to be constructed,partially or wholly, from previously herein described materials, as wellas to comprise of one or more of these materials, as may be generallyunderstood by those skilled in the art. Patches may also comprisebioactive materials and may also be for mechanical, biochemical andmedicinal purposes. The patch 600 may also be drug eluting, as known inthe medical implant arts. Furthermore, in one exemplary embodiment, thematerial of the patch 600 may contain a structure sufficient to readilypermit the passage of the distal portion of a shaft 461 of a fixationdelivery apparatus 400 with little or no resistance while providingresistance to the dislodging of an anchor 451 dispensed within orthrough patch 600.

Patch delivery tools 500 in accordance with the present inventions aregenerally configured to position one or more patches 200 at positions inproximity, adjacent or within an intervertebral disk 200 of a patient.Typically, patch delivery tools 500 are configured to releasably securedevices 600 on or about the distal portions of delivery tools 500 suchthat, after a surgeon has secured at least a portion of the patch 600 tothe intervertebral disk 200 of a patient, the patch 600 may be releasedfrom the patch delivery tool 500 and the patch delivery tool 500 may beremoved from the patient.

FIGS. 48A-48D illustrate exemplary embodiments of a fixation deliveryapparatus 400 in accordance with aspects of the present inventions. Asparticularly illustrated in FIGS. 48A-48D, the fixation deliveryapparatus 400 may include a delivery apparatus body 460, shaft 461,actuator 462, and a displacement rod 463. The illustrated fixationdelivery apparatus 400 may be configured to accommodate and sequentiallydeploy two or more anchors 451 of one or more fixation apparatuses 450.The illustrated fixation delivery apparatus may include a mechanism forregulating the advancing of displacement rod 463 for release of the twoor more anchors 451 of a fixation apparatus 450 from the shaft 461. Theembodiments of the fixation delivery apparatus 400 illustrated in FIGS.48A-48D are for exemplary purposes only. Any description of theseparticular figures not written in the permissive form is merely toexplain the nature and relationship of the particular components of theillustrated embodiments and is in no way intended to limit thedisclosure to the particularly illustrated components.

The delivery apparatus body 460 may include a body cavity 477 within atleast a portion of the delivery apparatus body 460. The deliveryapparatus body 460 may be elongated and include a handle 476 at theproximal portion of the delivery apparatus body 460. The shaft 461 maybe secured to the distal portion of the delivery apparatus body 460. Aguide, pin, or projection 484 may extend into the body cavity 477 andmay be received by slot or groove 485 of actuator 462 (see FIG. 480).

The shaft 461 extends from delivery apparatus body 460 and may include asheath 480. The shaft 461 may comprise a lumen 464 which may extend fromthe proximal portion to the distal portion of shaft 461. The lumen 464is illustrated with a circular cross-sectional shape that may besuitable to accommodate the circular cross-sectional shape of theillustrated anchors 451 and to slidably receive displacement rod 463,although, alternative cross-sectional configurations could be employedto accomplish the same function. The lumen 464 of the shaft 461 may bein communication with body cavity 477 of the delivery apparatus body 460and may permit the at least one displacement rod 463 and/or itscomponents to be slidably received within shaft 461. As illustrated, thedistal tip of the shaft 461 may be cut obliquely to form a sharp leadingsurface or point for ease of insertion into an intervertebral disc. Theshaft 461 may include a slot 465 along its side to accommodate portionsof fixation apparatus 450, such as elongate members 454, 466 and anchors451, and knots 455 that may not reside completely within lumen 464.

The actuator 462 and/or the displacement rod 463 may be movably receivedwithin a portion of body cavity 477. As illustrated, the actuator 462may function as a handle to interface with a user and extends proximallyfrom the proximal end of the delivery apparatus body 460. A distalportion of the actuator 462 may be secured to a proximal portion ofdisplacement rod 463. The displacement rod 463 is particularly shown assecured to the distal portion of the actuator 462. The actuator 462 mayconfigured to advance displacement rod 463 in a 1 to 1 ratio. Adisplacement spring 486 may be positioned within the body cavity 477between the distal portion of body cavity 477 and the distal portion ofactuator 462, in the example shown. The displacement spring 486 may biasthe illustrated actuator 462 and displacement rod 463 in a proximaldirection. A groove 485 on actuator 462 may be configured to cooperatewith the projection 484 of the delivery apparatus body 460. Thoseskilled in the art would realize this is an exemplary configuration and,for example, groove 485 could as easily be located on the apparatus body460 and the pin 484 could reside on the actuator 462.

The displacement rod 463 may generally be configured to apply a motiveforce to dispense T-anchors 451 from the distal end of the lumen 464and/or slot 465. The displacement rod, as shown, is an elongatedstructure having a substantially circular cross-sectional shape and maycomprise a displacement rod lumen 482 extending along at least a portionof the length of the displacement rod 463. At least a distal portion ofthe displacement rod 463 may be slidably received within the lumen 464of the shaft 461. The movement of the displacement rod 463 within lumen464 may be modulated by actuator 462. As particularly illustrated, theactuator 462 is configured to advance the displacement rod 463 in a 1 to1 ratio. A tether passage 483 may be defined in a proximal portion ofthe displacement rod 463. The tether passage 483 may permit a portion oftether 475 to extend from the displacement rod lumen 482 to bepositioned within body cavity 477 of the delivery apparatus body 460.Although tether 475 here is used as a general term, those skilled in theart would recognize that tether 475 could be a wire, string, suture bandor other elongate member to satisfy the same purpose.

The tether 475 may be provided to secure an anchor 451 prior todeployment. The proximal portion of tether 475 may be secured to theactuator 462, displacement rod 463, and/or delivery apparatus body 460.As illustrated, the tether 475 is secured to a portion of the actuator462. More particularly, the distal portion of the actuator 462 defines aflange 487 about which tether 475 is looped around the flange 487 tosecure the proximal end of the tether to the actuator 462.Advantageously, the distal end of the actuator 462 may have a tethersevering cavity 488 which includes a lip 489. In addition, a tethersevering element 490 may be provided in the distal portion of the bodycavity 477. The tether severing element 490 may include a cutting edge491. The tether severing cavity 488 and the tether severing element 490may cooperate to sever the tether 475 and thus allow anchor 451 to bereleased from lumen 464 and/or slot 465. As illustrated, the tether 475is cut by positioning the actuator 462 distally with the passage 483 andthe hp 489 of tether severing cavity 488 overlapping the longitudinalaxis of the cutting edge 491 of the tether severing element 490 to pressthe tether 475 against the cutting edge 491. Alternatively, if anautomated cutting feature is not used, a tether access portal 478 may beprovided through the delivery apparatus body 460 to permit access to thetether 475 with other cutting devices such as scissors or scalpels forexample. Although tether 475 is drawn as a single element residingwithin lumen 464 and connected to anchor 451, an alternative embodimentmay include tether 475 as a “looped” element wherein an end of thetether is passed through a receiving portion of anchor 451 and when, forexample, a single filament of the tether 475 is cut the filament passesdistally, through the anchor 451, and is removed with the deliveryapparatus 400. This alternative embodiment may allow the physician topractice the repair with one less step (i.e., the excising of thetrailing tether line 475 attached to anchor 451).

A sheath 480 may be secured about the outer surface of shaft 461. Thesheath 480 may extend from the delivery apparatus body 460 to a locationproximal to the distal end of shaft 461. A tissue stop 481 may besecured to the distal portion of shaft 461. As illustrated, the tissuestop 481 may also be particularly secured on sheath 480. The shaft 461may further define a slot 465. Slot 465 may be configured to slidablyreceive components of fixation apparatus 450 as the components slidealong the longitudinal axis of the shaft 461. As illustrated in FIG.48B, eyelets 466 comprised of looped elongate members 454 or filamentsextend from the slot 465 and bops 110 are interconnected by anadjustable elongate member 454, such as a cinch line 470 as shown.

The illustrated fixation apparatus 450 include three anchors 451 in FIG.48A and two anchors 451 in FIG. 48B. The anchors 451 are sequentially atleast partially positioned in a lumen 464 of shaft 461. As illustrated,the anchors 451 are configured as T-anchors, although those skilled inthe art would recognize other anchor configurations are possible toachieve the same effect. Each anchor 451 defines a transverse passagewhich receives a portion of a connecting member 454. As illustrated,elongate connecting member 454 comprises a filament bop or eyelet 466.As illustrated, filament bops or eyelets 466 are flexible lines formedinto loops which are secured within the transverse passages of theanchors by enlarged knotted portions. The filament bops 466 extendthrough the slot 465 from first anchor 452, the second anchor 453, and,when present, the third anchor 492, and are interconnected by anadditional elongate band 454 formed into a loop which passes through thepassages defined by each of the eyelets 466. The band 454 connecting theimplanted anchors 451 with their eyelets 466 includes a moveable knot455 which permits foreshortening of band 454. With foreshortening ofband 454, a trailing end of cinch line 470 may become longer as slack isremoved from the loop of band 454. A portion of band 454 may havesufficient length to extend outside the patient and form a cinch line470 which is accessible by a surgeon after implantation. A tab 493 maybe secured to the cinch line 470 to more easily facilitate the locatingand/or manipulating of the cinch line 470. The tab 493 may be removablysecurable to the shaft 461, as illustrated, or the delivery apparatusbody 460. Tab 493 may also be advantageously coupled (not shown) to body460, displacement rod 463, and/or actuator 462 so as to limit theability to slideable dispense anchors 451 until and/or when the surgeondesires; at which time, removal of tab 493 may allow dispensing of oneor more anchors 451. In addition, a cinch line holder 494 may beprovided on the delivery apparatus body 460, tab 493, shaft 461, or acombination of components of apparatus 400 so as to allow for linemanagement during the delivery and deployment of fixation apparatus 450.Holder 494 may include features that resistively allow controlleddispensing of line 470 during anchor deployment to assist in themanagement of the cinch line 470 during a surgical procedure. Resistanceon line 470 could be accomplished by the selective sizing of holder 494with respect to line 470. Alternatively, knotted elements (not shown)along line 470 could be received within holder 494 that comprisesmechanical interlocking components (not shown) so as to resistivelyimpede and provide controlled dispensing of line 470. Alternatively, acollet-type arrangement could be applied to the distal portion ofapparatus 400 so as to allow for resistive-like action in the managementof the delivery of fixation apparatus 450. These are intended to beillustrative examples of causing resistance and control of line 470elongate members 454 and apparatus 450, and should not be interpreted asbeing limiting as those skilled in the art would recognize a variety ofways to accomplish a similar effect.

As illustrated in FIG. 48D, a mechanism for regulating movement ofdisplacement rod 463 may generally include a guide 484 extending intobody cavity 477 and a groove 485 defined on the surface of the actuator462. The guide 484 on the delivery apparatus body 460 cooperates withthe groove 485 on the actuator 462 and may regulate at least the axialmovement of the displacement rod 463.

The guide, pin or projection 484 may be slidably received in groove 485of the actuator 462. The guide 484 may be secured to or within the bodycavity 477 of the delivery apparatus body 460. As illustrated, in FIG.48D, guide 484 is positioned within a guide cavity 495 and includes aguide spring 496 biasing the guide 484 outward into the body cavity 477.The illustrated guide 484 includes a flange which abuts a cavity flangeon a portion of the guide cavity 495 to prevent the guide 484 from beingdisplaced from the guide cavity 495. Note that guide 484, spring 496,body 460 and their cooperative relationship with groove 485 may alsoadvantageously allow for tactile and/or auditory feedback to the surgeonduring delivery of anchors as guide 484 passes along groove 485. Inalternative embodiments, the guide 484 could be otherwise rigidly ormovably secured within the body cavity 477 without departing from thescope of this aspect of the present inventions.

As illustrated in FIG. 48D, the groove 485 may extend along the outersurface of the actuator 462. The groove 485 may include longitudinallyextending portions 485 a and radial extending portions 485 b. Thelongitudinally extending portions 485 a may allow for longitudinaladvancing the actuator 462 and associated displacement rod 463. Theradially extending portions 485 b may function to stop the longitudinaladvancing of the actuator 462 and associated displacement rod 463. Thegroove 485 may also include a step 485 c wherein the depth of the groove485 increases. When the guide 484 is biased within the groove 485 forexample, the step 485 c could prevent, for example, further proximalwithdrawal of the actuator 462 and/or the displacement rod 463 from thebody cavity 477 beyond the point where the guide 484 contacts the step485 c.

In operation, the guide 484 may be initially positioned within a safetylock position 498 where the displacement rod 463 may be in a mostproximal position with respect to shaft 461 and wherein the actuator 462may be biased in a proximal position with respect to shaft 461 and/or bythe displacement spring 486, as seen in FIG. 48C. The tip of the shaft461 of the fixation delivery apparatus 400 may be positioned adjacent toa first location for insertion of the first anchor 452. The tip of theshaft 461 is inserted at the first location and the shaft 461 isadvanced into the intervertebral disc. In the illustrated embodiment,the motive force is typically applied to the delivery apparatus body 460by the surgeon. The shaft 461 may be advanced until the distal aspect ofthe tissue stop 481 contacts an outer surface of the intervertebral discor the tip of the shaft 461 has otherwise been determined to be at thedesired location within the intervertebral disc. The surgeon may notethat the shaft 461 has been properly advanced by the resistance tofurther movement resulting from the stop 481 or sheath 480 contactingthe outer surface of the intervertebral disc. Once properly positioned,the displacement rod 463 may be advanced relative to the deliveryapparatus body 460 by the surgeon to displace the first anchor 452 fromthe tip of the shaft 461 into the intervertebral disc. To do this, thesurgeon may distally displace the actuator 462 relative to the bodycavity 477 to release the guide 484 from the safety lock position 498.The actuator may then be rotated approximately 90 degrees sliding theguide 484 through a first radially extending portion 485 b of the groove485. The surgeon may then advance the actuator 462 distally within thecavity 477 which may slide the guide 484 through the first longitudinalextending portion 485 a of groove 485. This movement of the actuator maydisplace the first anchor 452 from the lumen 464 and/or slot 465 ofshaft 461 by distally advancing the displacement rod 463 a firstdistance. The first distance is selected to be sufficient to displacethe first anchor 452, but to be insufficient to eject the second anchor453. As the guide 484 reaches the proximal portion of the firstlongitudinal extending portion 485 a of groove 485, the guide 484 maypass over step 485 c and extend further into groove 485 due to forcesexerted on the guide 484 by guide spring 52. As seen in FIG. 48D, thefirst longitudinal extending portion 485 a of groove 485 may extendproximally beyond the second radially extending portion 485 b of groove485 to assure proper displacement of the first anchor 452 from shaft461. A surgeon would have to apply sufficient force to the actuator 462to slide the guide 484 to the most proximal portion of the firstlongitudinal extending portion 485 a of groove 485. Once the surgeonremoves the distally extending force on the actuator, the actuator isforced in a proximal direction by the displacement spring 486 untilguide 484 contacts the step 485 c preventing further proximal movementof the actuator 462 relative to delivery apparatus body 460. Thisproximal motion of the actuator 462 may function to draw the tetheredsecond anchor 453 proximally in lumen 464 and/or slot 465 of shaft 461dispensing the first anchor 452 from lumen 464. After the first anchor452 has been positioned at the first location within the intervertebraldisc, the shaft 461 of the fixation delivery apparatus 400 may bewithdrawn from the first location. The first anchor 452 is left securedwithin the intervertebral disc.

The second anchor 453 and fixation delivery apparatus 400 may remainsecured to the first anchor 452 connecting bands 454 such as 454, 466and/or trailing cinch line 470 of elongate bands, as shown in FIG. 48B.A loop in elongate member 454 may be configured to be at least longenough to extend from a first anchor location to a second anchorlocation prior to cinching band 454. The tip of shaft 461 of thefixation delivery apparatus 400 may be then repositioned adjacent to asecond location on the intervertebral disc for insertion of the secondanchor 453. The tip of the shaft 461 is inserted at the second locationand the shaft 461 is again advanced into the intervertebral disc. Theshaft 461 may again be advanced until the distal aspect of the tissuestop 481 or sheath 480 contacts an outer surface of the intervertebraldisc or the tip of the shaft 461 has otherwise been determined to be atthe desired location within the intervertebral disc. Once properlypositioned, the displacement rod 463 may be advanced relative to thedelivery apparatus body 460 by the surgeon to displace the second anchor453 from the tip of the shaft 461 into the intervertebral disc. To dothis, the surgeon may rotate the actuator approximately 90 degrees bysliding the guide 484 through a second radially extending portion 485 bof the groove 485. The surgeon may then advance the actuator 462distally within cavity 477 which may slide the guide 484 through thesecond longitudinal extending portion 485 a of groove 485. The movementof the actuator may displace the second anchor 453 from the distalportion of shaft 461 by distally advancing the displacement rod 463 asecond distance. The second distance being selected to be sufficient todisplace the second anchor 453 from the lumen 464 and/or slot 465 of theshaft 461 into the intervertebral disc. The surgeon then removes theshaft 461 from the intervertebral disc leaving the second anchor 453 atthe second anchor location within the intervertebral disc.

After insertion of at least the first anchor 452 and the second anchor453, the loop of elongate member 454 is shortened by hand or by pushingon, for example, a slip knot 455 with a knot-pusher or similar device toapply a force to the knot to slide the knot along the band 454 andreduce the size of the loop which tends to draw towards one another theanchors 451 and adjacent tissues surrounding an annular defect.Typically, the tightening is managed using a cinch line 470 that can bemanipulated by the surgeon. Once tightened, the excess cinch line 470can be cut.

When inserting the first anchor 452 and second anchor 453 in series, theelongate member 454 may have a tendency to lie across or along thesurface of the annulus fibrosus during the anchor insertion process. Forinstance, after the first anchor 452 has been inserted, since theelongate member 454 is connected to the first anchor 452 via itsrespective filament loop 466, a portion of the elongate member 454 maybe drawn toward and along the surface of the annulus fibrosus. Theelongate member 454 may thus interfere with movement of the tool 400and/or the ease of desired placement of the second anchor 453 therefrom.Accordingly, it may be desirable to provide a means for releasablyrestraining the elongate member 454 from release from the tool 400 untilafter or during the process of insertion of the second anchor 453.

FIG. 48 illustrates two additional exemplary means for management and/orretention of the elongate member 454. In one embodiment, a tether 471(shown in phantom in FIG. 48E) is looped about the elongate member 454,between its respective connections to the filament loops 466 of thefirst anchor 452 and the second anchor 453. The tether 471 is eithersecured to the tool 400 or retained in some other manner by the tooloperator to prevent complete release of the elongate member 454 from thetool 400, until at least during or after the insertion of the secondanchor 453. Alternatively, one or more portions of the elongate membermay be releasably secured to the tool 400 by an elastic band 473 (shownin phantom in FIG. 48E) or some other suitable releasable means. In thisinstance, the band retains one or more portions of the elongate member454 on the tool 400 (such as against the sheath 480 thereof. While theband 473 has sufficient retaining power to hold the elongate member 454onto the tool 400, it also is constructed so as to allow the elongatemember to slip therefrom during or after insertion of the second anchor453. The band 473 may be formed, in whole or in part, from an elasticmaterial that stretches to permit release of the elongate member 454from the tool 400. These examples are intended to illustrate additionalexemplary devices and methods to achieve management of the elongatemember 454 during deployment and insertion of its associated tissueanchors 451, and should not be interpreted as being limitingembodiments, as those skilled in the art would recognize a variety ofways to accomplish a similar effect.

It is contemplated that one or more fixation apparatuses 450 (and theirrespective delivery apparatuses 400) as illustratively described andshown in FIGS. 48A-48E could be used to effect annular repairs, butwithout the use of patch-like device 600 (and its respective deliverytool 500). It is possible that some annular defects may be readilyrepaired without the use of a patch-like device 600 and couldadvantageously be mended or otherwise repaired, partially or wholly,through tissue approximation. Exemplary of a re-approximation without apatch-like device could be performed with one or more repair apparatuses450 comprising anchors 451, loops 466, bands 454, retainers 455 andtethers 470, for example. In this alternative embodiment, tissuessurrounding an annular defect may be advantageously drawn towards oneanother to effect a repair, as previously described with respect to, forexample, FIGS. 7-13. One, two or more fixation apparatuses 450 may beused to accomplish the repair. These apparatuses may be positioned alongan annular aperture or may be conveniently placed in a non-linealfashion, such as a cruciate across the annular rent. It is alsopossible, given alternative presentations of annular defects, that are-approximation could also be performed that is similar to that of FIG.6 wherein fixation apparatuses 450 may be used in conjunction with afiller material 716 and without patch 600 present. In this alternativeembodiment, fill material 716 may be directly affixed, or otherwisesecured, to portions of one or more fixation devices 450 so as to retainfiller material 716 in proximity of the annular defect.

Furthermore, it is conceivable that, in order to repair anintervertebral disc annulus that is damaged, degenerated or otherwiseinfirmed with defects of a circumferential and/or delaminatedphysiology, one might employ one or more fixation devices 450 so as todraw together or otherwise radially stabilize or retain tissues in areparative fashion. In this alternative embodiment (which may beadditional or further described in co-pending application Ser. No.11/120,750) there may not be an annular aperture readily apparent in theintervertebral disc, but rather the degenerative pathology may berecognized as high intensity zones under radiological examination, suchas for example MRI and CT scans. It is also possible, given this type ofrepair, that the anchors 451 of apparatus 450 may be placed at spatiallyfar greater distances apart (prior to foreshortening band 454) than maybe needed for repair of annular apertures. For example, it isconceivable to repair some large posterior protrusions and/ordelaminations of an annulus that anchors 451 could be deployed as farapart as the total posterior, or more, of the annulus so as toreparatively restore or otherwise stabilize the incompetent annulartissue.

As noted herein, the anchors for annulus fibrosus tissue fixationapparatus may be disposed in annulus fibrosus tissue of a disc, in thedisc cavity for the nucleus polposus of the disc, through the entiredisc itself, or in or through Sharpey's Fibers or in a vertebral body. Afixation apparatus may include one or more anchors in any one or more ofany of these locations to facilitate the repair of a defect in the wallof the annulus fibrosus of a disc. Several exemplary embodiments offixation apparatus for making such a repair are illustrated in FIGS.49-69. These fixation apparatus embodiments described and illustratedmay be particularly useful when the defect is in proximity of a vertebra(as seen in FIG. 49) or when a portion of the defect is in proximity ofa vertebra (as seen in FIG. 58), although, they may be also useful evenwhen the defect is not adjacent to a vertebra, and therefor thedescription should not be construed as to limit their use. In theseembodiments, at least one anchor is disposed in a vertebra, and this, insome cases may provide a beneficial and stable fixation for the repairbeing made.

FIG. 49 is a lateral view, and FIG. 50 is a posterior view, both showinga superior vertebral body 202, inferior vertebral body 204 and anintervertebral disc 200 therebetween. The disc 200 has a defect oraperture 244 a in its annulus fibrosus 232. In this instance, theaperture 244 a is in proximity of the vertebral body 202, and may or maynot be within the Sharpey's Fibers between the annulus fibrosus 232 andvertebral body 202. A fixation apparatus 810 is shown in FIG. 49 to aidin closing the aperture 244 a. The fixation apparatus 810 includes atleast one anchor in the vertebral body 202 which, in cooperation with afixation device having a connection between one or more anchors in theannular fibrosus 232, can serve to draw annular fibrosus tissue towardthe vertebral body 202 in order to, partially or wholly, close theaperture 244 a.

FIGS. 49 and 50 illustrate the fixation apparatus 810 as affixed inplace on the vertebral body 202 and annulus fibrosus 232, prior torepair of the aperture 244 a. The fixation apparatus 810 includes asuitable bone anchor 811, illustrated in FIGS. 49 and 50 as a bonescrew. A shortenable elongate member 812 is slidably connected to thebone anchor 811, as through eyelet 813 thereon. In one embodiment, alength of the elongate member 812 is shortenable by means a moveableknot such as a Roeder knot or its functional equivalent. The length ofthe elongate member 812 can be shortened by puffing on its associatedtether 812 a to, for example, shorten the loop defined by the elongatemember 812. Together, the bone anchor 811 and elongate member 812 definea bone anchor assembly (although the bone anchor assembly is shown withonly one bone anchor connected to the elongate member, additional boneanchors and/or elongate members may be provided as an assembly).

As shown, one or more soft tissue anchors 814 may be affixed into orthrough the annulus fibrosus 232. In the illustrated embodiment, eachsoft tissue anchor 814 has a T-anchor 815 with an elongate element 816attached thereto. A link, connecting element or coupling 818 slidablyconnects the elongate elements 816 of each anchor 814. In oneembodiment, a length of the connecting element 818 is shortenable bymeans of a moveable knot such as a Roeder knot, or its functionalequivalent. The length of the connecting element 818 can be shortened bypulling on its associated tether 818 a to, for example, shorten the loopdefined by connecting element 818. Together, the soft tissue anchors 814and connecting element 818 define a soft tissue anchor assembly(although the soft tissue anchor assembly is shown with two anchorsconnected to the connecting element, additional soft tissue anchorsand/or connecting elements may be provided as an assembly).

In FIGS. 49 and 50, the fixation apparatus 810 is shown assembled butnot yet activated for repair of the aperture 244 a. In this assembledconfiguration, the connecting element 818 is disposed over a portion ofthe elongate member 812 at 820. Accordingly, once the fixation apparatus810 is assembled as illustrated, the portion 820 of the elongate member812 is slidably restrained by the soft tissue anchor assembly(incorporating, 815, 816, and 818).

FIG. 51 illustrates activation of the fixation apparatus 810 tofacilitate defect repair. The connecting element 818 has been shortenedby pulling on its associated tether 818 a (which is shown in dottedlines after having been cut away). Elongate member 812 has likewise beenshortened by pulling on its associated tether 812 a (which is also shownin dotted lines to illustrate it being cut away). The soft tissueanchors 814 and their associated connecting element 818 provide aneffective anchor assembly for the affixing elongate member 812 in theannulus fibrosus 232. Since the elongate member 812 is also anchored bythe bone anchor 811, the shortening of the length of the elongate member812 may be utilized to draw tissue of the annulus fibrosus 232 toward,at least partially, the vertebral body 202, thereby facilitating repairof aperture 244 a in the annulus fibrosus 232.

FIGS. 52-57B illustrate, in one embodiment, the placement and activationof fixation apparatus 810 proximate a defect in the wall of a disc'sannulus fibrosus. A bone drill 821 may be used to form a bore 822 in thesuperior vertebral body 202, after which (if needed), the bone anchor811 is inserted into the bore 822, as illustrated in FIG. 53. FIG. 53Aillustrates one means for introducing the bone anchor 811 into the bore822, such as an elongate element that is formed from a hollow tube orshaft 823 rotatably coupled to the bone anchor 811 (e.g., a bone screw).The shortenable elongate member 812 and its associated tether 812 a arereceived within the tube 823, or captured within or alongside the tube823, to prevent tangling thereof.

FIG. 54 illustrates the aligning of at least a portion 820 of theshortenable elongate element 812 along the annulus fibrosus 232, inproximity of a portion of the annulus to be repaired.

FIG. 55 illustrates one means for introducing soft tissue anchors 814into the annulus fibrosus 232. In the embodiment illustrated (in FIGS.55 and 55A) a tissue anchor delivery device 824 has a hollow needle orcannula 825 for slidably receiving each one of the tissue anchors 814therein. The device 824 may be similar in form and function to thedelivery tool 708 illustrated in FIG. 11, and otherwise disclosedherein. It is also contemplated that the anchor delivery tool candeliver the anchors 814 in series to the desired locations into and/orthrough the annulus fibrosus 232. One means for achieving retention ofthe elongate element 812 relative to the connecting element 818 is todispose one soft tissue anchor 814 on one side of the portion 820 of theshortenable elongate member 812, while disposing the other soft tissueanchor 814 on the other side thereof. This configuration is illustratedby the association of elements during tissue anchor delivery shown inFIG. 55A. As such, the connecting element 818 between soft tissueanchors 814 extends across, or spans, the portion 820 of the elongatemember 812.

FIG. 56 illustrates the fixation apparatus 810 as being delivered to thesoft tissue of the disc and vertebral body 202, with the tether 812 a ofthe shortenable elongate member 812 being pulled in direction of arrow826 (in FIG. 56, the associated tether 818 a of the link or coupling orconnecting element 818 has already been pulled to shorten the length ofconnecting element 818, and cut away). Once the length of theshortenable elongate member 812 has been shortened to an extentsufficient to cause the connecting element 818 for the soft tissueanchors 814 to be drawn in tension (pulling the tissue anchors 814toward one another), this may serve to pull, wholly or partially,annulus fibrosus tissue together. In addition, shortening the elongatemember 812 pulls the connecting element 818 (and its associated softtissue anchors 814) toward the bone screw 811, which may also serve topull, wholly or partially, annulus fibrosus tissue toward the bone screw811 in the vertebral body 202. In doing so, the aperture 244 a is dosed,repaired, or otherwise drawn to a smaller configuration. An exemplaryorientation and configuration for the activated fixation apparatus 810,with the lengths of both the connecting element 818 and elongate member812 shortened, is illustrated in FIG. 57, which shows fixation apparatus810 in both a lateral view (FIG. 57A) and a posterior view (FIG. 57B).

An alternative embodiment of a fixation apparatus having at least onebone anchor is illustrated in FIGS. 58-64. In this instance, the disc200 has a defect or aperture 244 b in its annulus fibrosus 232. In thisinstance, a portion of the aperture 244 b is also in proximity thevertebral body 20 (and may or may not be within the Sharpey's Fibersbetween the annulus fibrosus 232 and vertebral body 202), and anotherportion of the aperture 244 b is spaced from the vertebral body 202.Although the description and illustrations depict repairs of defects inproximity to vertebrae, this is illustrative and is not intended to belimiting the use of these devices. A fixation apparatus 830 is shown inFIG. 58 to aid in repair of defect 244 h. The fixation apparatus 830includes at least one anchor in the vertebral body 202 which, incooperation with a fixation device having a connection between one ormore anchors in the annulus fibrosus 232, can serve to draw annulusfibrosus tissue toward the vertebral body 202 in order to repair defect244 b.

FIG. 58 illustrates a fixation apparatus 830 as affixed in place tovertebral body 202 and annulus fibrosus 232, prior to closure of theaperture 244 b. The fixation apparatus 830 includes a suitable boneanchor 831, illustrated in FIG. 58 as a T-anchor. The bone anchor 831has a tether 831 a connected thereto, and the bone anchor 831 and aportion of the tether 831 a are inserted in the vertebral body 202. Boneanchor 831 may be delivered by pre-drilling a bone anchor bore 831 b, ifrequired. A shortenable elongate member 832 is slidably connected to thetether 831 a. In one embodiment, a length of the elongate member 832 isshortenable by means of a moveable knot such as a Roeder knot, or itsequivalent. The length of the elongate member 832 can be shortened bypulling on its associated tether 832 a to, for example, shorten the loopdefined by the elongate member 832. Together, the bone anchor 831 andelongate member 832 define a bone anchor assembly (although the boneanchor assembly is shown with only one bone anchor connected to theelongate member, additional bone anchors and/or tethers and/or elongatemembers 832 may be provided on the assembly).

In an alternative embodiment (not shown), tether 831 a may also includea slidable and locking element so as to be capable of shortening thedistance between the bone anchor 831 and elongate member 832.

As shown, one or more soft tissue anchors 834 may be affixed into orthrough the annulus fibrosus 232. In the illustrated embodiment, eachtissue anchor 834 has a T-anchor 835 with an elongate element 836attached thereto that extends into and/or through the annulus fibrosus232. A link, connecting element or coupling 838 slidably connects theelongate elements 836 of each tissue anchor 834. In one embodiment, alength of the coupling or connecting element 838 is shortenable by meansof a moveable knot such as a Roeder knot, or its functional equivalent.The length of the connecting element 838 can be shortened by pulling onits associated tether 838 a to, for example, shorten the loop defined bycoupling 838. Together, the tissue anchors 834 and connecting element838 define a soft tissue anchor assembly (although the soft tissueanchor assembly is shown with two soft tissue anchors coupled to aconnecting element, additional soft tissue anchors and/or connectingelements may be provided on the assembly).

In FIG. 58, the fixation apparatus 830 is shown assembled but not yetactivated for closure of the aperture 244 b in the annulus fibrosus 232.As shown, in this assembled configuration, the connecting element 838 isdisposed over a portion 840 of the elongate member 832. Accordingly,once fixation apparatus 830 is assembled as illustrated, the portion 840of the elongate member 832 may be slidably restrained between the softtissue anchors 834 and the connecting element 838. FIG. 59 illustratesactivation of the fixation apparatus 830 to facilitate defect repair.The elongate member 832 has been pulled to shorten the length thereofbetween the bone anchor tether 831 b and the elongate member 832 bypulling on the free end of the member 832 a (which is shown in dottedlines after having been cut away). The connecting element 838 has beenshortened by pulling on its associated tether 838 a (which is shown indotted lines after having been cut away). As stated previously, tether831 a may also be capable of being shortened (not shown), to facilitatethe defect repair. Soft tissue anchors 834 and theft associatedconnecting element 838 provide an effective anchor assembly foranchoring to the annulus fibrosus 232. Since the elongate member 832 isalso, as illustrated, anchored by the bone anchor 831, the shortening ofthe length of the elongate member 832 may act to draw tissue of theannulus fibrosus 232 toward the vertebral body 202, thereby urgingclosure of the aperture 244 b. In the embodiment illustrated in FIGS. 58and 59, since the tissue anchors 834 have also been placed on oppositesides of the portion of the aperture 244 b, the shortening of thelengths of the associated connections between the tissue anchors 834 andthe bone anchor 831 also serves to urge annulus fibrosus tissue togetherbetween the tissue anchors 834, thereby further providing stabilizationof tissue surrounding defect 244 b in the annulus fibrosus 232.

FIGS. 60-64 illustrate, in one embodiment, the placement and activationof fixation apparatus 830 proximate a defect in the wall of a disc'sannulus fibrosus. A bone drill may be used to form the bore 831 b in thesuperior vertebral body 202 that is contiguous to the disc 200, adjacentthe aperture 244 b in the annulus fibrosus 232. The bone anchor 831 isinserted into the bore 831 b and suitably manipulated to be securedwithin the vertebral body 202 with the tether 831 a extending throughthe bore 831 b and outwardly therefrom. This arrangement is illustratedin FIG. 61, which also illustrates the aligning of at least a portion840 of the shortenable elongate element 832 along the annulus fibrosus232, proximate to the aperture 244 b therein.

FIG. 62 illustrates a fixation apparatus 830 with tissue anchors 835(not shown) thereof (and their associated connecting element 838, shown)already introduced into or through the annulus fibrosus 232. The tissueanchors 834 can be introduced by various anchor delivery devices, asdisclosed herein, and either in parallel or sequentially. One means forachieving retention of the elongate member 832 relative to theconnecting element 838 is to dispose one tissue anchor 834 on one sideof the portion 840 of the shortenable elongate member 832, whiledisposing the other tissue anchor 834 on the other side thereof. Assuch, the connecting element 838 between tissue anchors 834 extendsacross or spans the portion 840 of the elongate member 832.

FIG. 62 illustrates the fixation apparatus 830 as now assembled withrespect to the annulus fibrosus 232 and vertebral body 202, with tether832 a of the shortenable elongate member 832 ready to be pulled toshorten the length of the elongate member 832. As illustrated, theassociated tether 838 a of the link or coupling or connecting element838 has already been pulled to shorten the length of the connectingelement 838 (and has been cut away in FIG. 62). Shortening elongatemember 832 may be sufficient to cause coupling 838 and tissue anchors834 to be drawn in tension pulling, wholly or partially, annulusfibrosus tissue together. In addition, shortening the elongate member832 may additionally draw connecting element 838 toward the bone anchor831, thus pulling wholly or partially, annulus fibrosus tissue towardthe vertebral body 202. In doing so, the defect 244 b is dosed,repaired, or otherwise stabilized. An exemplary orientation andconfiguration for activated fixation apparatus 830 is illustrated inFIGS. 63 and 64, which show fixation apparatus 830 with the lengths ofboth the connecting element 838 and elongate member 832 shortened.

As noted above, the tissue anchors 834 may be disposed in the annulusfibrosus 232 at the same time, using a delivery tool such as illustratedin FIGS. 11 and 55. In addition, the bone anchor 831 may also bedelivered by such a delivery tool. Alternatively, all of the anchors maybe delivered by a single delivery tool, similar to those illustrated inFIGS. 13 and 48. FIG. 65 illustrates schematically the disposition of ananchor 831 capable of being anchored into bone and soft tissue anchors835 capable of being delivered into soft tissue (e.g., first anchor 835a and second anchor 835 b) within a shaft 861 of an anchor delivery tool860. In this instance, the shaft 861 has a lumen 864 therein adjacentits distal end, and the shaft 861 has a slot 865 associated with thelumen 864 to accommodate the various tethers, connections and/or knotsbetween and among the bone anchor 831 and tissue anchors 835 (tethers,connections and/or knots not shown in FIG. 65). In one embodiment, boneanchor 831 is the first anchor to be disposed within a patient's tissue,and is advanced by manipulation of a displacement rod 863 that isslidably disposed within the lumen 864 of the shaft 861. The form andoperation of the displacement rod 863 relative to the shaft 861 andassociated anchors therein is accomplished in a similar manner to thatillustrated by the device 400 in FIG. 48. Movement of the displacementrod 863 (in direction of arrow A in FIG. 65) dispenses, in sequence, theanchors 831, 835 a and 835 b out of the shaft 861 of the tool 860. Thesecond soft tissue anchor 835 b has an eyelet 874 or other suitablemeans for slidably engaging a tether 875 therefor. In one embodiment,the tether 875 extends proximally through a displacement rod lumen 882in the displacement rod 863, and both proximal ends of the tether 865are affixed to portions of a handle (not shown) of the delivery tool860. While one proximal end remains affixed to the tool, the otherproximal end of the tether 875 is severed by manipulation of thedelivery tool 860 once the second tissue anchor 835 b has been disposedin a desired location in the annulus fibrosus 232 (see, e.g., tether 475and tether severing element 490 on tool 400 in FIG. 48C). The tether 875is thus free to be removed from the second tissue anchor 835 b, byslipping it through the eyelet 874 thereon as the delivery device tool860 is withdrawn. Prior to its being cut, the tether 875 for the secondtissue anchor 835 b serves the same purpose as the tether 475 for theanchor 453 illustrated in FIG. 48 and explained above. Such anarrangement (to retain the second soft tissue anchor 835 b) could alsobe provided for the first soft tissue anchor 835 a. Moreover, it isconceivable to have multiple anchors capable of being anchored to boneas well as multiple soft tissue anchors in one tool, with the order ofdelivery not expressed as illustrated in FIG. 65, but workable in theopposite order, or in a different fashion.

FIG. 66 illustrates another embodiment for repair of a defect that isproximate to a vertebral body. In this instance, the fixation apparatusfor facilitating closure of the defect further includes a patching,scaffolding, filling-type element. In all of the fixation apparatusembodiments disclosed herein, it may be possible to provide a patch tofurther aid in the repair, reconstruction or closure of a defect, suchas a patch 600 as discussed and illustrated in this disclosure.

In the fixation apparatus embodiment of FIG. 66, patch 600 is retainednot only within the nucleus of the disc 200, it also extends through atleast a portion of a defect 244 c therein and is affixed to a vertebralbody, such as superior vertebral body 202. The patch 600 may take anysuitable form for a patch, such as disclosed herein. The patch 600 has afirst portion 600 a to which a bone anchor 811 has been inserted andsecured to the vertebral body 202. The first portion 600 a of the patch600 is also covered, on its exposed surfaces, by a non-adhesion material601, which may be retained thereon in part by the bone anchor 811, whichhas an enlarged head 811 a thereon for that purpose. A second,intermediate portion 600 b of the patch 600 extends through at least aportion of the defect 244 c in the annulus fibrosus 232. A third portion600 c of the patch 600 extends along an inner face of the wall of theannulus fibrosus 232. One or more tissue anchors 814 are inserted intothe annulus fibrosus 232 and through the third portion 600 c of thepatch 600, to affix the patch 600 to the annulus fibrosus 232, as seenin FIG. 66. An exemplary tissue anchor assembly for this purposecomprises at least one tissue anchor 814 having a T-anchor 815 with anelongate element 816 attached thereto that extends into and/or throughthe annulus fibrosus 232. A shortenable elongate member 812 is slidablyconnected to the bone anchor 811, as through an eyelet 813 thereon. Inone embodiment, a length of the elongate member 812 is shortenable bymeans of a moveable knot, such as a Roeder knot, or its functionalequivalent. The length of the elongate member 812 can be shortened bypulling on its associated tether 812 a to, for example, shorten the loopdefined by the elongate member 812. In the manner illustrated in FIG.66, or using the types of fixation apparatus illustrated herein (suchas, for example, those shown in FIGS. 49-64), a patch 600 can beadditionally employed to aid in closure of a defect in an annulusfibrosus, particularly where the defect is proximate to a vertebralbody. By shortening the length of the elongate member 812, the annulusfibrosus tissue adjacent any tissue anchors 814 therein is drawn towardthe bone anchor 811 in the vertebral body 202, thereby urging dosed thedefect 244 c and urging annulus fibrosus tissue against the secondportion 600 b of the patch 600 in the defect 244 c. Although FIG. 66illustrates the patch-like material being affixed by the bone anchor, itis clear that a similar repair could be performed without directlyaffixing the patch with the anchor. For example, a tether or otherconnective element could attach patch 600 to anchor 811. However, patch600 may merely be affixed to the annulus with anchors.

As noted in the illustrative embodiments herein (see, e.g., FIGS. 2C,7A, 19, 49, 58 and 66), a suitable bone anchor can take a variety offorms, such as a bone screw 811 or T-anchor 831 (or even a bone anchorthat extends completely through a bone, such as seen in FIG. 19). Thebone screw may be self tapping, or may require a pre-drilled bore in thevertebral body for reception thereof. Likewise, depending upon thedelivery tool, a T-anchor type bone anchor 831 may be self penetrating,or may require a pre-drilled bore formed in the vertebral body. Asuitable bone anchor may take alternative forms, such as a barb, anexpandable element and/or an adhesive element. FIG. 67 illustrates abone anchor 811 formed as an exemplary bone screw, while FIG. 68illustrates a bone anchor 831 formed as an exemplary T-anchor. Asillustrated in the exemplary embodiments of FIGS. 67 and 68, each boneanchor has a shortenable elongate member 812 connected thereto. Theelongate member 812 may comprise a bop (as shown) or a tether or someother suitable shortenable means. The elongate member may comprise aline, wire, filament, band or suture.

An expandable mesh bone anchor may also be used as a holding deviceinside of a vertebral body. The mesh anchor can have pre-attached tetherelements attached thereto (e.g., sutures in the form of a shortenableelongate element) for connecting the bone anchor to its complementarytissue anchor or tissue anchor assembly in the annulus fibrosus. Forinsertion, an expandable mesh bone anchor has a small diameter. Onceinserted into the vertebral body, the bone anchor opens up to a largerdiameter and includes some means for locking the bone anchor in itslarger diameter deployed shape. For use as an anchor in a vertebralbody, an expandable bone mesh anchor is inserted through a pre-drilledhole and then deployed (i.e., expanded) inside the cancellous bone andseated up against the harder cortical bone, which allows for a strongsupporting structure. The porous mesh formed by a deployed expandablemesh bone anchor construct also allows for growth in and around theconstruct. The bone anchor may also take the form of an adhesive orexpandable material disposed onto or inserted into a vertebral body, oran adhesive may be used in conjunction with other types of bone anchors,such as a bone screw, T-anchor, barb or expandable element.

FIG. 67 illustrates a bone anchor 811 in the form of a bone screw with ashortenable elongate member 812 slidably connected thereto through aneyelet 813 on the bone anchor 811. A Roeder knot 85B on the elongatemember 812 leads to an associated tether 812 a. Once the bone screw 811is anchored, puffing on the tether 812 a away from the bone anchor 811shortens the loop defined by the elongate member 812. FIG. 68illustrates a bone anchor 831 in the form of a T-anchor. The T-anchorhas a bore 885 extending therethrough for a slidable reception of thetether 831 a therein. On one side of the T-anchor, the tether 831 a isknotted, such as at knot 886. One the other side of the T-anchor, thetether 831 a leads to a Roeder knot 831 c formed about the shortenableelongate member 832. Once the bone anchor 831 has been affixed in place,pulling on the free end of the tether 831 a shortens the length betweenthe knot 831 c and the bone anchor 831. As noted above, the elongatemember 832 also has a Roeder knot 832 b thereon. Once the bone anchor831 has been affixed in place, puffing on the tether 832 a in adirection away from the bone anchor 831 shortens the loop defined by theelongate member 832.

FIG. 69 is an illustration of a tissue anchor assembly, such as thatillustratively deployed in the exemplary embodiments of FIGS. 49 and 58.Each tissue anchor 814 has a T-anchor 815 with an elongate element 816attached thereto. In this embodiment, each T-anchor 815 has a pair ofbores 887, 888 therethrough for slidable reception of portions of theelongate element 816. On one side of the T-anchor 815, the elongateelement 816 is knotted, such as at knot 889, to affix it to the T-anchor815. In one embodiment, each elongate element 816 defines a bop. A linkor connecting element or coupling 818 slidably connects the loops of theelongate elements 816 of each tissue anchor 814. In one embodiment, thecoupling 818 also defines a loop, and the loop of the coupling 818extends through the loops of the elongate elements 816, as shown in FIG.69. The connecting element 818 has a Roeder knot 816 b thereon. Once thetissue anchors 814 are affixed in place, pulling on the tether 818 a ofthe connecting element 818 in direction away from the tissue anchors 814shortens the loop defined by the connecting element 818. FIG. 69illustrates two tissue anchors 814, such as illustrated in the exemplaryembodiments of FIGS. 49 and 58. FIG. 69 also illustrates, in phantom,that a third anchor 814 may be provided in slidable connection with theconnecting element 818. Additional tissue anchors, as desired for theapplication at hand, may also be provided. Such a third anchor (or evenmore tissue anchors, if desired) may be attached to the connectingelement 818, and inserted into or through the annulus fibrosus tissue ata location (for each additional anchor) that is spaced from theinsertions of the first and second tissue anchors. In one embodiment,the connecting element 818 between anchors is shortenable (such as, forexample, by applying tension thereto) to draw those inserted anchorstoward one another, and to cause a drawing together of annulus fibrosustissue proximate to those anchors. In addition, while the connectingelement 818 is shown as a loop, it may be possible to also achieve thesame result (a shortenable link or coupling or connection) using atether or some other suitable shortenable means. The coupling maycomprise a line, wire, filament, and or suture.

While the fixation apparatus embodiments illustrated in FIGS. 49-69illustrate tissue anchors formed as T-anchors, it is understood that anysuitable tissue anchors such as those disclosed herein will suffice solong as the tissue anchor provides a suitable platform forinterconnection with one another (whether or not they are bony tissue orsoft tissue anchors) via a shortenable elongate element. For instance, afurther suitable anchor that may be used as a tissue anchor (bony orsoft) comprises a dual T-anchor implant. In this anchor arrangement (seeFIGS. 70-73), two T-anchors are attached together via one or more suturelines. The T-anchors may be of the type having a single boretherethrough (such as the T-anchors illustrated in FIGS. 68 and 70-71)or having two bores therethrough (such as the T-anchors illustrated inFIGS. 69 and 72-73).

FIG. 70 illustrates schematically two T-anchors connected by a singlesuture line and mounted for insertion in a delivery tool (shown inphantom) to ultimately form a dual T-anchor implant. An anchor deliverytool 960 has a distally slotted shaft 961 with a lumen 964 therein forreception, in series, of a first T-anchor 951 a and a second T-anchor951 b. Each T-anchor 951 a and 951 b has at least one bore 985therethrough, for slidable reception of a single anchor tether 925therein. On one side of the second T-anchor 951 b, the tether 925 has aknot 926 thereon of size sufficient to prevent passage through the bore985 of the second T-anchor 951 b. The first and second T-anchors 951 aand 951 b may be inserted into patient tissue in series, as discussedherein. Once inserted, pulling on the tether 925 in a direction awayfrom the first and second anchors 951 a and 951 b pulls the anchorstogether as illustrated, for example, in FIGS. 71A and 71B. The firstand second anchors 951 a and 951 b may line up in a generally parallelalignment, as indicated in FIG. 71A, or may be rotationally skewedrelative to their respective bores, as illustrated in FIG. 71B. On theone hand, when aligned as seen in FIG. 71A, the second anchor 951Bcreates a support structure for the first anchor 951 a, which in turnmakes for a more robust anchor. On the other hand, when aligned as seenin FIG. 71B, an anchor arrangement having greater surface area restingagainst patient tissue may be provided, which also may be advantageous.While both anchors should be of a size that may be received in the shaft961 of the tool 960, the first and second anchors 951 a and 951 b may beof the same length or of different lengths. For example, the secondanchor 951 b may be shorter than the first anchor 951 a.

FIG. 72 illustrates schematically an alternative dual T-anchor implant.In FIG. 72, two anchors are again aligned for sequential insertionwithin an anchor delivery tool 1060 (shown in phantom) having a shaft1061. In this arrangement, a first anchor 1051 a and a second anchor1051 b are provided. Each anchor has at least two bores therethrough(such as the T-anchors 814 illustrated in FIG. 69), such as bores 1087and 1088. A single elongate element 1016 slidably is received withineach of the bores 1087 and 1088. At some point along the length of theelongate element 1016, it is knotted together (as at knot 1089) to formthe elongate element 1016 into a continuous loop. The dual T-anchorimplant illustrated in FIG. 72 can be sequentially inserted from thetool 1060, as disclosed herein. Once inserted, pulling on the loop 1060in a direction away from the first and second anchors 1051 a and 1051 bpulls the second anchor 1051 b into engagement and alignment (generallyparallel) under the first anchor 1051 a, as illustrated in FIG. 73. Thiscreates a support structure for the first anchor, which in turn makesfor a more robust anchor. While both anchors should be of a size thatmay be received in the shaft 961 of the tool 960, the first and secondanchors 1051 a and 1051 b may be of the same length or of differentlengths. For example, the second anchor 1051 b may be shorter than thefirst anchor 1051 a. In either exemplary construct illustrated in FIGS.70-73, the use of a dual T-anchor implant arrangement serves to providea larger, more robust anchor, without increasing the diameter of thelumen of the shaft of the anchor delivery tool.

FIG. 74 illustrates a system 2000 for repairing an aperture or a defectin an intervertebral disc according to another embodiment of the presentinvention. As shown in FIG. 74, the system 2000 includes a pair offixation delivery apparatus 2010, 2016, a bone awl 2020, and a knotpusher 2024. As shown and as discussed in further detail below,releasably coupled to the fixation delivery apparatus 2010 is a fixationapparatus 2030 configured to be deployed and attached to a vertebralbody (e.g., the vertebral bodies 202 or 204 illustrated in FIG. 9above). Additionally, releasably coupled to the fixation deliveryapparatus 2016 is a fixation apparatus 2034 configured to be deployedand attached to vertebral disc tissue. The fixation apparatus 2030 andthe fixation apparatus 2034 are configured to form a completed repairsystem for closing a defect or aperture in the annulus fibrosus asexplained in the various embodiments described and illustrated above,for example, in FIGS. 58-64 and/or FIG. 69 above and the correspondingdetailed description. In various embodiments, the bone awl 2020 and/orthe knot pusher 2024 are optional, and thus may be omitted from thesystem 2000.

FIG. 75A is a partial cutaway illustration of the fixation deliveryapparatus 2010 with the fixation apparatus 2030 coupled thereto, andFIG. 75B is a cross-sectional view of a portion of the fixation deliveryapparatus 2010 taken along the line 75B-75B. As shown, the fixationdelivery apparatus 2010 includes a tubular shaft 2050 and a proximalhandle 2054 coupled thereto. In the illustrated embodiment, the shaft2050 terminates in a relatively blunt distal tip 2055, and furtherincludes a tissue stop 2056, although these elements are, in variousembodiments, optional. The fixation delivery apparatus 2010 furtherincludes an actuator 2060 coupled to an ejection rod 2064, and a pair oftabs 2066, 2067 releasably coupled to a portion of the actuator 2060. Asfurther shown, the delivery apparatus 2010 includes a spring 2068 in thehandle 2054 positioned to bias the actuator 2060 axially away from thehandle 2054.

The fixation apparatus 2030 is partially disposed within the tubularshaft 2050, with a pair of tethers 2070, 2072 of the fixation apparatus2030 extending external to the delivery apparatus 2010 and connected tothe tabs 2066, 2067, respectively. The fixation apparatus 2030 is, inone embodiment, configured to anchor a suture assembly (including aportion of the tether 2070) to a vertebral body adjacent to anintervertebral disc annulus having an aperture or defect to be repaired.Thus, in one embodiment, the fixation apparatus 2030 can include a boneanchor (not shown) such as the bone anchor 831 of the bone anchorfixation apparatus 830 illustrated in FIGS. 58-64 and described in thecorresponding text above. In one embodiment, the fixation apparatus 2030includes the bone anchor 831 illustrated in FIG. 68 above, and thetethers 2070, 2072 correspond, respectively, to the tethers 832 a and831 a illustrated in the construct of FIG. 68. Thus, in the assembledand undeployed state of the fixation delivery apparatus 2010 andfixation apparatus 2030 shown in FIG. 75A, the bone anchor is positionedwithin the tubular shaft 2050, and is coupled to the tether 2072.

In the illustrated embodiment, the ejection rod 2064 is partiallyslidably disposed within the tubular shaft 2050, and is configured toeject the bone anchor of the fixation apparatus 2030 from the tubularshaft 2050 into the desired implantation location (e.g., a pre-formedanchor bore in the vertebra 202 or 204 such as shown in FIG. 58 above)by manipulation of the actuator 2060. Thus, the actuator 2060 isslidable relative to the handle 2054 to effectuate axial movement of theejection rod 2064. As shown, the actuator 2060 includes a knob 2076 formanipulation by the user. In various embodiments, the actuator 2060 andthe handle 2054 further include additional features that allow theactuator 2060 and, in turn the ejection rod 2064, to be advanced indiscrete steps, e.g., to selectively and sequentially eject multiplebone anchors in series, in much the same manner as described above withrespect to the 400 shown in FIGS. 48A-48E and described in thecorresponding text.

The tab 2066 is releasably coupled to a portion of the actuator 2060and, in the undeployed state of FIG. 75A, is positioned so as to preventspontaneous axial movement of the actuator 2060 and, in turn, theejection rod 2064. Additionally, the tether 2070 is connected to the tab2066, which can be manipulated by the user to apply tension to thetether 2070 to adjust the length of the suture assembly connected to thebone anchor (such as shown in FIGS. 58-64 and 68 above). In addition,the tether 2072 is connected to the tab 2067, which can be manipulatedby the user to facilitate engagement of the bone anchor with thevertebral body once deployed therein, in various embodiments, connectingthe tether 2072 to the tab 2067 further provides an additional means toprevent unintentional deployment of the bone anchor from the shaft 2050of the fixation delivery apparatus 2010. In other embodiments, only asingle tether and single tab may be provided.

FIG. 76A is a partial cutaway illustration of the fixation deliveryapparatus 2016 with the fixation apparatus 2034 coupled thereto, andFIG. 76B is a cross-sectional view of a portion of the fixation deliveryapparatus 2016 taken along the line 76B-76B. As shown in FIG. 76A, thefixation delivery apparatus 2016 includes a tubular shaft 2080 and aproximal handle 2084 coupled thereto. In the illustrated embodiment, theshaft 2080 terminates in a sharpened, tissue-piercing distal tip 2085and includes a tissue stop 2086. The fixation delivery apparatus 2016further includes an actuator 2090 coupled to an ejection rod 2094, andat least one tab 2096 releasably coupled to a portion of the actuator2090. As further shown, the delivery apparatus 2016 includes a spring2098 in the handle 2084 positioned to bias the actuator 2090 axiallyaway from the handle 2084.

The fixation apparatus 2034 is partially disposed within the tubularshaft 2080, with at least one tension line 2100 of the fixationapparatus 2034 extending external to the delivery apparatus 2016 andconnected to the tab 2096. The fixation apparatus 2034 is, in oneembodiment, configured to anchor a suture assembly (including thetension line 2100) to the intervertebral disc annulus having an apertureor defect to be repaired. In various embodiments, the fixation apparatus2034 is configured in a similar or identical manner as the soft tissuefixation apparatus illustrated in FIGS. 58-64, or the fixation apparatus450 illustrated in FIGS. 48A-48E and described in the correspondingtext. Thus, in one embodiment, the fixation apparatus 2034 can include apair of tissue anchors (not shown in FIG. 76A) such as the soft tissueanchors 834 illustrated above in FIGS. 58-64, connected by an adjustableconnecting element configured to be shortened to place the deployedtissue anchors in tension to facilitate closure of the aperture ordefect, again as discussed in connection with the various embodimentsillustrated above. In various other embodiments, the fixation apparatus2034 is configured to be substantially identical to the fixationapparatus 450 shown in FIGS. 48A-48E, and thus includes a pair of tissueanchors 452, 453 connected by an adjustable elongate member 454. Thus,in the assembled and undeployed state of the fixation delivery apparatus2016 and fixation apparatus 2034 shown in FIG. 76A, the tissue anchors(not shown) are positioned within the tubular shaft 2080.

The fixation delivery apparatus 2016 may, in most respects, have thesame general functionality as, for example, the fixation deliveryapparatus 400 described above and illustrated in FIGS. 48A-48E. Thus,the ejection rod 2094 is partially slidably disposed within the tubularshaft 2080, and is configured to eject the tissue anchors of thefixation apparatus 2034 from the tubular shaft 2080 into the desiredimplantation location within the disc annulus by manipulation of theactuator 2090. Thus, the actuator 2090 is slidable relative to thehandle 2084 to effectuate axial movement of the ejection rod 2094. Asshown, the actuator 2090 includes a knob 2116 for manipulation by theuser. In various embodiments, the actuator 2090 and the handle 2084further include additional features that allow the actuator 2090 and, inturn the ejection rod 2094, to be advanced in discrete steps, e.g., toselectively and sequentially eject multiple bone anchors in series, inmuch the same manner as described above with respect to the fixationdelivery apparatus 400 of FIGS. 48A-48E.

In various embodiments, the fixation delivery apparatus 2016 includesadditional features also present in the fixation delivery apparatus 400.For example, the shaft 2080 may, in various embodiments, include a slotto facilitate loading and management of the fixation apparatus 2034. Inaddition, the fixation delivery apparatus 2016 may also include meansfor managing the elongate connecting member connecting the tissueanchors of the fixation apparatus 2034, similar or identical to theelastic band 473 shown in FIG. 48E.

Similar to the tab 2066 of the fixation delivery apparatus 2010, the tab2096 is releasably coupled to a portion of the actuator 2090 and, in theundeployed state of FIG. 76A, is positioned so as to prevent spontaneousaxial movement of the actuator 2090 and, in turn, the ejection rod 2094.Additionally, the tension line 2100 is connected to the tab 2096, whichcan be manipulated by the user to apply tension to the tension line 2100to facilitate adjustment, i.e., shortening, of the connecting assemblybetween the tissue anchors, e.g., using the knot pusher 2024 (see FIG.74).

In use, the physician can use the bone awl 2020 (or other suitableinstrument) to form an access bore in the vertebra 202 or 204 (see,e.g., FIG. 52) into which the bone anchor of the fixation apparatus 2030can be inserted. Next, the distal tip 2055 of the fixation deliveryapparatus 2010 is inserted into the access bore up to the tissue stop2056. The tab 2067 (to which the tether 2072 is connected) is thenremoved from the actuator 2060 and set aside. The bone anchor of thefixation apparatus 2034 is then deployed into the vertebra 202 or 204 bymanipulation of the actuator 2060. Next, the bone anchor is toggled bypulling on the tab 2067, thus applying tension to the tether 2072 (whichas discussed above, is also connected to the bone anchor). Thus, byapplying tension to the tether 2072, the bone anchor positively engagesthe vertebra to secure the bone anchor therein. For example, when thebone anchor 831 of FIG. 68 is utilized, toggling the bone anchor 831 byapplying tension to the tether 2072 (corresponding to the tether 831 aof FIG. 68) causes the relatively sharp end of the bone anchor 831 toengage the vertebral body.

Next, the fixation apparatus 2034 is deployed into the disc annulusfibrosus using the fixation delivery apparatus 2016 to facilitatepartial or complete closure of the aperture in the annulus fibrosus. Theconfigurations of the fixation apparatus 2034 during and afterdeployment are substantially identical or identical to theconfigurations of the soft tissue anchor assembly shown in FIGS. 58-64and described in the corresponding text.

FIG. 77 is an elevation view of a fixation delivery tool 2300 and afixation apparatus 2310 coupled thereto according to another embodimentof the present invention. In various embodiments, the fixation deliverytool 2300 and the fixation apparatus 2310 can be used in lieu of thebone screw 811 and delivery tool 823 illustrated in FIG. 53A above.Alternatively, in other embodiments, the fixation delivery tool 2300 andthe fixation apparatus 2310 can be used in lieu of the fixation deliveryapparatus 2010 and the fixation apparatus 2030 discussed above andillustrated in FIGS. 74 and 75 above. Thus, the fixation apparatus 2310can, in various embodiments, be deployed in conjunction with thefixation apparatus 2034 to facilitate repair of an aperture in anannulus fibrosus of an intervertebral disc.

As shown in FIG. 77, the fixation delivery apparatus 2300 includes ashaft 2316 and a handle 2320. The shaft 2316 includes a proximal end2322 and a distal end 2324, with the proximal end 2322 connected to thehandle 2320. As further shown, the fixation apparatus 2310 includes abone screw 2325 coupled to the distal end 2324 of the fixation deliveryapparatus 2300. The fixation delivery apparatus 2300 is operable by auser to screw the bone screw 2325 into the patient's vertebra adjacentto the disc annulus to be repaired. As will be illustrated and describedin greater detail below, the fixation apparatus 2310 further includes aflexible connecting element 2030 shown exiting the handle 2320 of thefixation delivery apparatus 2300 in FIG. 77.

FIG. 78 is a further illustration of the fixation apparatus 2310. Asshown, the fixation apparatus 2310 includes the flexible connectingelement 2330, e.g., an adjustable suture assembly, connected to the bonescrew 2325. In the illustrated embodiment, the connecting elementincludes an adjustable loop 2334 and a connecting segment 2336. Alocking element 2338, e.g., a slip knot or Roeder knot as illustrated,is formed in the adjustable loop 2334, and a tension line 2339 extendsaway from the adjustable loop 2334 and can be accessed by the user toadjust the dimensions of the adjustable loop 2334. The connectingsegment 2336 is connected to the bone screw 2325, and the adjustableloop 2334 is in turn connected to the connecting segment 2336. In use,the connecting element 2330 can have substantially the same or identicalfunctionality as the elongate member 812 coupled to the bone screw 811described above in connection with FIGS. 49-57.

FIG. 79A is a detailed view of the bone screw 2325, and FIG. 79B is across-sectional elevation view of the bone screw 2325. As shown, thebone screw 2325 has a threaded shaft 2340 with a proximal end portion2344 and a distal tip portion 2348. The proximal end portion 2344 has aproximal end 2350 and is shaped, e.g., with a hexagonal cross-sectionalshape, to mate with a complementary shape in the distal end 2324 of theshaft 2316 of the delivery tool 2310 so as to enable torque applied tothe delivery tool 2310 to be transferred to the bone screw 2325 toenable the user to screw the bone screw 2325 into the vertebra asdesired. In various embodiments, the distal tip portion 2348 has aself-tapping configuration so as to eliminate the need for a pre-formedhole in the vertebra into which the bone screw 2325 is to be implanted.

As can perhaps be best seen in the cross-sectional view of FIG. 79B, thegeneral shape of the bone screw 2325 defines a longitudinal axis 2360,and the bone screw 2325 includes an open lumen 2366 originating at theproximal end 2350. As further shown, the lumen 2366 exits the bone screw2325 laterally at a location between the proximal end 2350 and thedistal tip portion 2348. Additionally, the inner surface of the lumen2366 includes a chamfered or radiused region 2368 at the proximal end2350 of the bone screw 2325.

In the illustrated embodiment, the lumen 2366 includes a proximalsegment 2370 extending substantially parallel to the longitudinal axis2360 from the proximal end 2350, and a lateral segment 2376 extendingfrom the proximal segment 2370. As shown, the proximal segment 2370 hasa smaller diameter than the lateral segment 2376, thus forming ashoulder 2380 at the junction of the proximal and lateral segments 2370,2376.

For illustration purposes, the connecting segment 2336 of the connectingelement 2330 is shown inserted in the lumen 2366 in FIG. 79B to show thefunctionality of the lumen 2366. As shown in FIG. 79B, the connectingsegment 2336 is fed through the lumen 2366 and exits the open end of thelumen at the proximal end 2350 of the bone screw 2325. Additionally, theconnecting segment 2336 includes a stop feature 2384 (e.g., a knot orpledget) having a diameter larger than the diameter of the proximalsegment 2370 of the lumen 2366. Accordingly, the stop feature 2384engages the shoulder 2380 thus preventing the connecting segment 2336from being pulled axially from the lumen 2366. Additionally, tensionapplied to the connecting segment 2336, i.e., by puffing on the tensionline 2339 of the connecting element 2330, is thus transferred to thebone screw 2325 by the engagement of the stop feature 2384 and theshoulder 2380.

The configuration of the bone screw 2325 advantageously allows theconnecting segment 2336 to exit the bone screw 2325 parallel to thelongitudinal axis 2360, thus allowing the bone screw 2325 to be threadedinto the vertebra with the proximal end 2350 flush or substantiallyflush with the outer surface of the vertebra. Additionally, the radiusedregion 2368 of the inner surface of the lumen at the proximal end 2350provides strain relief and reduces frictional wear on the connectingsegment 2336 due to contact against the bone screw 2325.

As explained above, the fixation apparatus 2310 including the bone screw2325 and the adjustable connecting element 2330 can be used insubstantially the same manner as the bone screw 811 and the elongatemember 812 described above and illustrated in FIGS. 49-57. Accordingly,the fixation apparatus 2310 can be employed in conjunction with a softtissue anchoring assembly such as described above and illustrated inFIG. 48A-48E, 49-57, or 58-64, to facilitate closure of an aperture inthe intervertebral disc.

It will be appreciated that the particular configurations of the variousadjustable elongate members and connecting elements associated with thesoft tissue anchors and bone anchors/screws described and illustratedabove are exemplary only. Accordingly, other configurations of theseadjustable elongate members and connecting elements can be employedwithin the scope of the various embodiments of the present invention.

All patents referred to or cited herein are incorporated by reference intheir entirety to the extent they are not inconsistent with the explicitteachings of this specification, including; U.S. Pat. No. 5,108,438(Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Rayet al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331(Oucheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No.5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.),U.S.Pat. No. 5,376,120 (Sarver et al.) and U.S. Pat. No. 5,976,186 (Bao etal.).

Various materials know to those skilled in the art can be employed inpracticing the present invention. By means of example only, the bodyportions of the stent could be made of NiTi alloy, plastics includingpolypropylene and polyethylene, polymethylmethacrylate, stainless steeland other biocompatible metals, chromium cobalt ahoy, or collagen.Webbing materials can include silicone, collagen, ePTFE, DACRON,polyester, polypropylene, polyethylene, and other biocompatiblematerials and can be woven or non-woven. Membranes might be fashioned ofsilicone, polypropylene, polyester, SURLYN, PEBAX, polyethylene,polyurethane or other biocompatible materials. Inflation fluids formembranes can include gases, liquids, foams, emulsions, and can be orcontain bioactive materials and can also be for mechanical, biochemicaland medicinal purposes. The stent body, webbing and/or membrane can bedrug eluting or bioabsorbable, as known in the medical implant arts.

Further, any of the devices or delivery tools described herein, orportions thereof, could be rendered visible or more visible viafluoroscopy, if desired, through the incorporation of radioopaquematerials or markers. Preferably implantable devices are constructedwith MRI compatible materials. In particular, devices and/or theircomponents could be wholly or partially radiopaque, as result of, forexample: compounding various radiopaque materials (e.g., bariumsulphate) into device materials; affixing radiopaque materials to devicestructures (e.g., bands of platinum, gold, or their derivative alloys);deposition of radiopaque materials onto device structures (e.g.,deposition of platinum, gold of their derivative alloys); processingradiopaque materials into device structures (e.g., braiding/weavingplatinum or gold wires or its alloy derivatives). One inventive way toachieve radiopacity of a device described herein, for example treatmentdevice 600, is placing one or more radiopaque marker bands ontofilaments of braided device 600 before (or possibly after) creating endpotions of the device.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

We claim:
 1. A system for at least partially closing a defect in softtissue of a patient, the system comprising: a first fixation deliveryapparatus having a tubular shaft, and a proximal handle a first fixationapparatus releasably coupled to the first fixation delivery apparatusincluding a bone anchor configured to be deployed at least partiallyinto and attached to a bone structure adjacent to the soft tissueincluding the defect, and an adjustable flexible connecting elementconnected to the bone anchor, wherein at least a portion of the boneanchor and a portion of the adjustable connecting element are disposedwithin the tubular shaft of the first fixation delivery apparatus priorto deployment of the first fixation apparatus, and wherein the flexibleconnecting element can be manipulated by a user to adjust a lengththereof; a second fixation delivery apparatus including a tubular shafthaving a sharpened tissue-piercing distal tip, a proximal handle coupledto the tubular shaft, an ejection rod slidably disposed within thetubular shaft, and an actuator slidably coupled to the handle andoperatively coupled to the ejection rod; and a second fixation apparatusreleasably coupled to the second fixation delivery apparatus including apair of soft tissue anchors and an adjustable flexible connectingelement connecting the soft tissue anchors, wherein the soft tissueanchors and a first portion of the flexible connecting element aredisposed within the tubular shaft and a second portion of the flexibleconnecting element is releasably coupled to the handle of the secondfixation delivery apparatus prior to deployment, wherein the bone anchoris configured to be attached to the bone structure, the soft tissueanchors are configured to be deployed within and attached to the softtissue with the defect located between the bone anchor and the softtissue anchors, and the flexible connecting elements of the firstfixation apparatus and the second fixation apparatus are configured tobe interconnected and placed in tension to at least partially close thedefect in the soft tissue.
 2. The system of claim 1 wherein the firstfixation delivery apparatus further includes an actuator slidablycoupled to the handle and connected to an ejection rod slidably disposedwithin the tubular shaft, and a releasable tab coupled to the actuator,and wherein the actuator and the ejection rod are configured to ejectthe bone anchor from the tubular shaft, and wherein at least a portionof the adjustable connecting element of the first fixation apparatus isconnected to the releasable tab, and wherein the tab is positioned toprevent axial movement of the actuator relative to the handle whencoupled to the actuator.
 3. The system of claim 2 wherein the releasabletab of the first fixation delivery apparatus is further operable by auser to change an orientation of the bone anchor after the bone anchoris ejected from the tubular shaft.
 4. The system of claim 3 wherein thereleasable tab of the first fixation delivery apparatus is operable by auser to at least partially rotate the bone anchor after the bone anchoris ejected from the tubular shaft of the first fixation deliveryapparatus and deployed at least partially within the bone structure. 5.The system of claim 4 wherein the bone anchor is a T-anchor having arelatively sharp end, and wherein in use, the relatively sharp end isconfigured to engage the bone structure upon manipulation of thereleasable tab of the first fixation delivery apparatus by the user. 6.The system of claim 1 wherein the bone anchor is a bone screw.
 7. Thesystem of claim 6 wherein the bone screw is a self-tapping bone screw.8. The system of claim 6 wherein the portion of the adjustableconnecting element disposed within the tubular shaft of the firstfixation delivery apparatus exits the first fixation delivery apparatusproximate the handle.
 9. The system of claim 6 wherein the bone screwhas a longitudinal axis, a proximal end, a self-tapping distal tip, athreaded region between the proximal end and the distal tip, and an openlumen originating at the proximal end and exiting the bone screwlaterally between the proximal end and the distal tip, and wherein theflexible connecting element of the first fixation apparatus includes aconnecting segment partially disposed within the lumen and exitingtherefrom at the proximal end of the bone screw.
 10. The system of claim9 wherein the lumen includes a first segment extending longitudinallyfrom the proximal end of the bone screw generally parallel to thelongitudinal axis, and a second segment extending at an oblique anglerelative to the longitudinal axis.
 11. The system of claim 10 whereinthe first segment has a first cross-sectional dimension and the secondsegment has a second cross-sectional dimension larger than the firstcross-sectional dimension so as to form a shoulder at an intersection ofthe first and second segments.
 12. The system of claim 11 wherein theconnecting member includes a stop feature configured to engage theshoulder to substantially prevent the connecting member from beingpulled from the lumen.
 13. The system of claim 1 wherein the connectingelements of the first and second fixation apparatus each include alocking element to maintain the respective connecting elements in ashortened configuration under tension.